[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

REGULATORY REFORM SERIES, PART 5--FDA MEDICAL DEVICE REGULATION: IMPACT
ON AMERICAN PATIENTS, INNOVATION, AND JOBS

=======================================================================

HEARING

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

FIRST SESSION

__________

JULY 20, 2011

__________

Serial No. 112-78

Printed for the use of the Committee on Energy and Commerce

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana ANTHONY D. WEINER, New York
ROBERT E. LATTA, Ohio JIM MATHESON, Utah
CATHY McMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi JOHN BARROW, Georgia
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BILL CASSIDY, Louisiana DONNA M. CHRISTENSEN, Virgin
BRETT GUTHRIE, Kentucky Islands
PETE OLSON, Texas KATHY CASTOR, Florida
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

Subcommittee on Oversight and Investigations

CLIFF STEARNS, Florida
Chairman
LEE TERRY, Nebraska DIANA DeGETTE, Colorado
SUE WILKINS MYRICK, North Carolina Ranking Member
JOHN SULLIVAN, Oklahoma JANICE D. SCHAKOWSKY, Illinois
TIM MURPHY, Pennsylvania MIKE ROSS, Arkansas
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
MARSHA BLACKBURN, Tennessee EDWARD J. MARKEY, Massachusetts
BRIAN P. BILBRAY, California GENE GREEN, Texas
PHIL GINGREY, Georgia DONNA M. CHRISTENSEN, Virgin
STEVE SCALISE, Louisiana Islands
CORY GARDNER, Colorado JOHN D. DINGELL, Michigan
H. MORGAN GRIFFITH, Virginia HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)

(ii)

C O N T E N T S

----------
Page
Hon. Cliff Stearns, a Representative in Congress from the State
of Florida, opening statement.................................. 1
Prepared statement........................................... 4
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 6
Prepared statement........................................... 8
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 10
Prepared statement........................................... 11
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 13
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 13
Hon. Lee Terry, a Representative in Congress from the State of
Nebraska, opening statement.................................... 14
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 20
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 20
Prepared statement........................................... 23
Hon. Gene Green, a Representative in Congress from the State of
Texas, prepared statement...................................... 255
Hon. John Dingell, a Representative in Congress from the State of
Michigan, prepared statement................................... 256

Witnesses

Robert E. Fischell, Chairman and CEO, Fischell Biomedical LLC.... 25
Prepared statement........................................... 28
Carol Murphy, Patient............................................ 33
Prepared statement........................................... 35
Marti Conger, Patient and Patient Advocate....................... 38
Prepared statement........................................... 40
Pam K. Sagan, Patient............................................ 49
Prepared statement........................................... 51
Michael Mandel, chief Economic Strategist, Progressive Policy
Institute...................................................... 54
Prepared statement........................................... 56
Sean Ianchulev, Chief Medical Officer, Transcend Medical Inc..... 66
Prepared statement........................................... 68
Gregory D. Curfman, Executive Editor, New England Journal of
Medicine....................................................... 73
Prepared statement........................................... 75
Additional comments for the record........................... 257
Jeffrey E. Shuren, Director, Center for Devices and Radiological
Health, Food and Drug Administration........................... 184
Prepared statement........................................... 186
Answers to submitted questions............................... 263

Submitted Material

New York Times article, ``Medical Treatment, Out of Reach,''dated
February 9, 2011, by Andrew Pollack, submitted by Mr. Terry.... 15
Democratic Supplemental Memorandum, dated July 20, 2011,
submitted by Ms. DeGette....................................... 93
Letter, dated July 15, 2011, from Gregory D. Curfman, Executive
Editor, New England Journal of Medicine, to Mr. Waxman,
submitted by Ms. DeGette....................................... 99
Letter, dated July 15, 2011, from Rita F. Redberg, Professor of
Medicine, to Mr. Waxman, submitted by Ms. DeGette.............. 102
Letter, dated July 17, 2011, from Rita F. Redberg, Professor of
Medicine, to Mr. Waxman, submitted by Ms. DeGette.............. 105
Letter, dated July 18, 2011, from Howard Bauchner, Editor in
Chief, JAMA and Scientific Publications, to Mr. Waxman,
submitted by Ms. DeGette....................................... 108
Letter, dated July 18, 2011, from Jeanne Ireland, Assistant
Commissioner for Legislation, Food and Drug Administration, to
Mr. Waxman, submitted by Ms. DeGette........................... 111
Study, ``A Comprehensive Analysis of the FDA 510(k) Process:
Industry Practice and the Implications for Reform,'' dated May
25, 2011 (revised July 19, 2011), by Northwestern University,
submitted by Mr. Stearns....................................... 119
Premarket Approval record, PMA Number 92005-S038, dated September
12, 2007, for Medtronic Sprint Leads, Implantable
Cardiovascular Defibrillator, submitted by Mr. Gingrey......... 235
Statement, dated July 20, 2011, by AdvaMed on the House Energy
and Commerce Subcommittee Hearing on FDA Device Regulation,
submitted by Mr. Waxman........................................ 236
Slides, undated, accompanying testimony by Mr. Shuren, submitted
by Ms. DeGette................................................. 239
Letter, dated March 1, 2011, from Massachusetts Congressional
Members to David R. Challoner, Institute of Medicine, submitted
by Mr. Burgess................................................. 250
Letter, dated April 13, 2011, from Hon. John F. Kerry to Margaret
Ann Hamburg, Commissioner, Food and Drug Administration,
submitted by Mr. Burgess....................................... 252

REGULATORY REFORM SERIES, PART 5--FDA MEDICAL DEVICE REGULATION: IMPACT
ON AMERICAN PATIENTS, INNOVATION, AND JOBS

----------

WEDNESDAY, JULY 20, 2011

House of Representatives,
Subcommittee on Oversight and Investigation,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Cliff
Stearns (chairman of the subcommittee) presiding.
Members present: Representatives Stearns, Terry, Myrick,
Sullivan, Burgess, Blackburn, Bilbray, Gingrey, Scalise,
Gardner, Griffith, Lance, Barton, DeGette, Schakowsky, Green,
Christensen, Dingell and Waxman (ex officio).
Staff present: Clay Alspach, Counsel, Health; Carl
Anderson, Counsel, Oversight; Karen Christian, Counsel,
Oversight; Todd Harrison, Chief Counsel, Oversight and
Investigations; Sean Hayes, Counsel, Oversight and
Investigations; Sean Hayes, Counsel, Oversight and
Investigations; Kirby Howard, Legislative Clerk; Debbee Keller,
Press Secretary; Ryan Long, Chief Counsel, Health; Carly
McWilliams, Legislative Clerk; Alan Slobodin, Deputy Chief
Counsel, Oversight; Sam Spector, Counsel, Oversight; John
Stone, Associate Counsel; Tim Torres, Deputy IT Director;
Kristin Amerling, Democratic Chief Counsel and Oversight Staff
Director; Phil Barnett, Democratic Staff Director; Stacia
Cardille, Democratic Counsel; Stephen Cha, Democratic Senior
Professional Staff Member; Brian Cohen, Democratic
Investigations Staff Director and Senior Policy Advisor; Eric
Flamm, FDA Detailee; Karen Lightfoot, Democratic Communications
Director and Senior Policy Advisor; Ali Neubauer, Democratic
Investigator; and Mitch Smiley, Democratic Assistant Clerk.
Mr. Stearns. Good morning, everybody, and the subcommittee
will come to order and I will open with my opening statement.

OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA

We convene this hearing of the Subcommittee on Oversight
and Investigations to examine FDA's medical device regulations
and their impact on American patients, innovation and jobs. The
medical device industry has brought hundreds of thousands of
high-paying jobs to our country and life-saving, life-improving
devices to our Nation's patients in a safe and efficient
manner.
Unfortunately, it appears that regulatory inconsistency and
inefficiency at FDA is causing innovative medical device
companies to move offshore and launch their products abroad,
oftentimes years before they enter the U.S. market, if at all.
These are systemic problems at the Center for Devices and
Radiological Health, CDRH, that must be resolved that are not a
matter of funding.
A Congressional Research Service report issued in April
2010 found that medical device review process funding increased
from $275 million in fiscal year 2008 to $368 million in fiscal
year 2010. This represents nearly a 35 percent increase in
funding. Comparing 2010 with the 2003 to 2007 time period, the
average review time for lower-risk devices approved through the
510(k) process increased by 43 percent and the average review
time for higher-risk, innovative devices under the premarket
approval system increased 75 percent.
President Obama himself has acknowledged that he has gotten
a lot of commentary about the fact that essentially FDA's model
was designed for the kind of medical devices you see in
museums. In reference to his Administration's purported
commitment to regulatory reform, he noted that this would be an
area where they should be ``getting a group to think
strategically about how we design these regulatory bodies so
that they are up to speed and more responsive in a dynamic
economy.'' Unfortunately, in the eyes of the Administration,
this group does not appear to include the innovative, job-
creating companies or the very patients that these devices are
designed to help.
For example, FDA commissioned the Institute of Medicine,
IOM, to review the current 510(k) process and consider a number
of specific issues related to the improvement of device
regulations. Not a single company or industry representative
that is impacted by these regulations is on the panel. Judging
from a letter sent by Senator Al Franken to CDRH Director,
Jeffrey Shuren, our witness today, Senator Franken and others
share my concerns. In it, he states, ``I believe that the
medical device industry contains a wealth of expertise that is
too often neglected when considering changes to the device
review process. I strongly encourage you to establish a clear
process for soliciting and considering the suggestions and
concerns of the medical device industry on any and all
recommendations made by the IOM before finalizing or
implementing any changes to the process.'' In addition to the
stunning lack of industry representation, there is not a single
patient representative on the panel. This is not acceptable and
does not comply with President Obama's call for allowing
``public participation and an open exchange of ideas.''
In addition, CDRH is supposed to ``use the least
burdensome'' tools for achieving regulatory ends. This is not
only a key tenet of the President's Executive Order on
Regulatory Reform, but required by the Food and Drug
Modernization Act of 1997. Specifically, in order to improve
regulatory efficiency of the 510(k) and premarket approval
process, Congress mandated that the FDA eliminate unnecessary
burdens that may delay the marketing of beneficial new products
and only request the least burdensome information necessary to
make those determinations. Unfortunately, FDA appears to be
actively thwarting the mandates of Congress and fostering
regulatory uncertainty by reducing its use of the least
burdensome provisions.
Now, whether this is a calculated effort or a lack of
leadership in promoting such principles, the end result is
equally unacceptable: companies closing their doors and moving
abroad; patients in the United States waiting for innovative
treatments or being forced themselves to go abroad to get them.
We will hear today from several of these patients.
Hopefully, Dr. Shuren will gain some insight from these
experiences and better understand the fact that patient safety
and public health are not only jeopardized by approving devices
that are unsafe, but also by failing to approve devices that
are safe. Such poor processes and decision-making also stifle
innovation, cutting-edge American companies that create
numerous badly needed jobs here in the United States. As FDA
Commissioner Hamburg said just this past week, ``This is a
critical time for innovation.'' She acknowledged that FDA has
played a role in the national decline in medical product
innovation, adding that she felt much of the criticism of her
agency was deserved. Hopefully we can find some solutions to
reverse this alarming trend today and soon. Patients are
waiting.
[The prepared statement of Mr. Stearns follows:]

[GRAPHIC] [TIFF OMITTED] T3314.001

[GRAPHIC] [TIFF OMITTED] T3314.002

Mr. Stearns. With that, I recognize the ranking member, Ms.
DeGette.

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO

Ms. DeGette. Thank you very much, Mr. Chairman, for holding
this hearing.
The topic of medical devices hits very close to home with
me and I am very, very interested in this topic, because just
like Ms. Sagan's daughter, my daughter, Francesca, has type 1
diabetes and has had type 1 diabetes for 13 years, and so I
know every day what children living with these diseases, and
young adults living with these diseases need to do with
devices--blood sugar monitoring, making sure they eat healthy
meals and daily exercise. For the generation of kids like our
two kids, Ms. Sagan's and mine, the short-term cure is medical
devices. My daughter and probably Ms. Sagan's daughter uses an
insulin pump and a continuous glucose monitor every day and
yet--Ms. Sagan, I read your testimony and it broke my heart
because every single parent who has a child living with this
disease knows the scary low blood sugars and the scary thought
about some of the consequences that can happen with this
disease, but for our children, good devices have been the cures
and the treatment for them and what will continue to be the
treatments for them in their lives.
Now, unfortunately, some of the advances in these
technologies, not just for diabetics but for other diseases,
seem to so many of us to have been so slow over at the FDA, and
the perfect example is in Ms. Sagan's testimony where she talks
about our efforts to get a continuous glucose monitor approved
that would send a message to the pump and would cut off insulin
flow if the blood sugar is way too low.
Mr. Chairman, I want to thank you and many members of this
committee for signing a letter by the Diabetes Caucus urging
the FDA to look at this device because it can literally save
lives, and we appreciate it, and this is true not just for
these devices but for devices that millions of Americans use
for countless different diseases. On the one hand, people are
relying on devices, and on the other hand, we want to make sure
that improvements and advances in those devices and new devices
are approved with speed. But on the other hand, we need to make
sure that the FDA has the appropriate tools to make sure that
medical device approval process helps encourage innovation
while at the same time protecting patient safety, and that's
the challenge I think that the FDA faces and I think that
that's the challenge that we all face on this committee is
making sure that while we support the FDA expediting an
approval process that we make sure that the reviews are done in
a way that is safe for those patients and for those devices. We
need to find the right balance and we can't pretend that there
aren't sometimes tradeoffs between safety and speed.
Now, I am sympathetic to the industry concerns we hear
today but I also fear that too often the device industry and
also people like me who are eager to see cures and treatments
for diseases kind of minimize those tradeoffs between safety
and speech. Two studies funded by the medical device industry,
one conducted by Dr. Josh Makower and the other by the
California Healthcare Institute, that have been heavily cited
by many of our colleagues and by proponents of weakening FDA
regulations provide a good example of how facts can be twisted.
These studies have been heavily cited, and so our committee
staff asked a panel of distinguished outside reviewers to
analyze the methodology of these studies, and at the staff's
request, officials from the FDA also submitted comments on the
studies.
Mr. Chairman, Democratic committee staff prepared a
supplemental memo summarizing the expert reviews of these
industry studies, and I would ask unanimous consent to include
this memo and the letters from FDA and the independent experts
in today's hearing record.
Mr. Stearns. I thank the gentlelady. Can we just have a
copy of it and we will read it and we will look at it.
Ms. DeGette. You bet.
The reviewers found the following problems with these
industry-funded studies. First, the existence of ``so many
flaws in design and execution that the authors' conclusions are
rendered essentially meaningless.'' Second, a ``woefully
inadequate'' response rate of only 20 percent, a biased group
of respondents that included companies that had never gone
through the process of getting a product reviewed by the FDA, a
subjective, apples to oranges, and especially troublesome
conclusion regarding the difference in approval times between
the European Union and the United States, the failure to
provide any evidence that a U.S. delay in approval and
availability leads to adverse health outcomes. The journal
editors concluded that the studies would not be fit for
publication in a peer-reviewed journal.
And so as we consider the role of the FDA, we have got to
rely on the facts. The patients and their families and the
industry need to know how can we have the quickest review
process possible while at the same time ensuring patient safety
and efficacy of the devices.
So I thank you for having this hearing. I look forward to
both of our panels of testimony, and I yield back.
[The prepared statement of Ms. DeGette follows:]

[GRAPHIC] [TIFF OMITTED] T3314.003

[GRAPHIC] [TIFF OMITTED] T3314.004

Mr. Stearns. I thank the gentlelady, and the gentleman from
Texas, Mr. Barton, is recognized for 1 minute.

OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS

Mr. Barton. Thank you, Mr. Chairman. Thank you and Ranking
Member DeGette for holding this oversight hearing.
The issues that we are discussing today have the ability to
harm our sick, inhibit innovation and stifle domestic economic
jobs and growth. On the other hand, if done properly, they have
the ability to bring state-of-the-art medical devices quickly
and efficiently to not only the United States citizenry but to
people all over the world. I hate to say it, but the medical
device review process at the Food and Drug Administration in my
opinion has become overly burdensome, unpredictable and
inconsistent under its current leadership.
I would like to read briefly a paragraph from the document
that was prepared for this hearing, which is common themes
raised by the device companies seeking FDA approval include
unclear guidance, high turnover of review staff, impractical
clinical designs, changing the goalpost, reluctance to approval
protocols, and duplicative or overly burdensome data requests.
Hopefully, this hearing will lead to some soul searching at
the FDA, and if necessary, it may lead to some legislative
solutions recommended by this subcommittee to the legislative
subcommittees.
I will put the rest of my statement in the record, Mr.
Chairman, but this is an important hearing and it has important
implications for the country.
[The prepared statement of Mr. Barton follows:]

[GRAPHIC] [TIFF OMITTED] T3314.005

[GRAPHIC] [TIFF OMITTED] T3314.006

Mr. Stearns. I thank the gentleman.
The gentleman from Texas, Dr. Burgess, is recognized for 1
minute.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS

Mr. Burgess. Thank you, Mr. Chairman, and Dr. Shuren, thank
you for being here. Thank you for your willingness to hear from
the panel and of course I want to thank our panelists for being
here. Ms. Conger, thank you for reminding us if we are not
careful, NIH stand in the future for Not Invented Here.
Now, the FDA is not interactive, it is unpredictable and
discourages innovation, and this ultimately hurts patients. We
don't want the FDA to approve anything that will harm people.
We don't want you to simply adopt European standards. But we do
want you to understand that a little predictability can go a
long way. We want you held to your own standards. If you say 30
days, we shouldn't have to ask how long is that in FDA days. If
a company is asked to provide proof the device does something
it wasn't designed to do and they tell you that, you can't
claim that as an example of noncompliance. I know you care
about the FDA. You know I care about the FDA. And you do have a
critically important job, but don't hide behind a twisted
interpretation of benchmarks.
The truth, the doctors of tomorrow are going to have tools
at their disposal that are unlike anything that you or I
imagined during our training. The ability to alleviate human
suffering is going to be on a scale never imagined before by
any other generation of doctors. It is our job to be certain
that the tools get into their hands.
Thank you, Mr. Chairman. I will yield back.
Mr. Stearns. I recognize the gentleman from Georgia, Dr.
Gingrey, for 1 minute.

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA

Mr. Gingrey. Mr. Chairman, thank you.
I focused my opening statement during the July 11th
prescription drug user fee hearing on my intent to pursue
regulatory reform through PDUFA reauthorization building on the
steps that the FDA and Dr. Hamburg have already taken. The same
is true for medical devices. Patients, industry and the FDA can
benefit from a more predictive regulatory framework. With
limited financial resources, as outlined by the chairman, both
within the FDA and in industry, it appears that an approval
approach that is able to maximize effort is one that will
benefit all, and I believe that if the FDA is going to be
successful and becoming more responsive to new technologies and
products, it is going to need the support of industry experts,
patient advocates and other agencies.
I look forward to working with this committee and Dr.
Hamburg to ensure we achieve this worthy goal. I thank both
panels of witnesses. We look forward to hearing from you, and I
yield back.
Mr. Stearns. I thank the gentleman.
The gentleman from Nebraska, Mr. Terry, is recognized for 1
minute.

OPENING STATEMENT OF HON. LEE TERRY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEBRASKA

Mr. Terry. Thank you. My statement is going to reference
the February 9th article from the New York Times that I would
like to submit for the record, unanimous consent to submit.
Mr. Stearns. Without objection, so ordered.
[The information follows:]

[GRAPHIC] [TIFF OMITTED] T3314.007

[GRAPHIC] [TIFF OMITTED] T3314.008

[GRAPHIC] [TIFF OMITTED] T3314.009

[GRAPHIC] [TIFF OMITTED] T3314.010

[GRAPHIC] [TIFF OMITTED] T3314.011

Mr. Terry. Biosensors International, a medical device
company, shut its operation in southern California, which had
once housed 90 people, 90 lost jobs. The CEO is moving the
manufacturing to Europe and says their stent ``is available all
over the world including Mexico and Canada but not in the
United States. We decided, let's spend our money in China,
Brazil, India and Europe.'' It is disappointing to hear the
CEO's statement.
We hear later in the article a quote from a capital venture
company who says, ``Ten years from now, we'll all get on planes
and fly somewhere else to get treated.'' That is a true
indictment of our FDA's inability to timely approve medical
devices, and I would like to see us, the United States,
continue to be the world leaders in technology development.
Yield back.
Mr. Stearns. I thank the gentleman.
The gentlelady from Tennessee, Ms. Blackburn, is recognized
for 1 minute.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE

Mrs. Blackburn. Thank you, Mr. Chairman, and welcome to all
of our witnesses. We are grateful that you would take your time
and be here with us today.
Continuing on the theme of making these innovations, having
the innovations here, I think it is important for us to realize
that 40 percent of the global medical technology industry is
here in the United States, and it represents about 2 million
U.S. jobs. Where I am from in Tennessee, we have about 10,000
individuals who are employed in the medical device industry and
the wages and earnings are about 40 percent higher than the
average earnings. So when you look at it from an issue of
keeping those jobs here, it is vitally important.
When you look at the fact that we are in a 21st century
creative economy and innovation, intellectual property and
protecting that is vital to jobs retention. We want to make
certain that FDA is responsive and responsive in a timely
manner.
Welcome to the hearing, and I look forward to questions.
Mr. Stearns. I thank the gentlelady.
The ranking member from California, Mr. Waxman, is
recognized for 5 minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Mr. Waxman. Thank you, Mr. Chairman, for holding this
important hearing today.
I think we can all agree it is critically important that
innovation in the medical device industry is vibrant and
healthy, and that patients have access to the best and newest
technological advances. If FDA is unnecessarily impeding
technological advances that improve the lives of patients, we
should all be united in doing whatever it takes to remove these
unnecessary regulatory barriers to public health.
But we cannot have a conversation about the impact of
regulations and policies at FDA have on patient access and
innovation without talking about the importance of ensuring the
safety and effectiveness of medical devices. We should not
forget that that is the fundamental mission of FDA.
Practically every month, there is a new report in the
papers about horrific patient suffering from dangerous medical
devices. Last year, the New York Times revealed that radiation
machines have killed and disfigured patients. The Subcommittee
on Health held a hearing on the issue and heard from a father
whose son was killed by an overdose from radiation therapy. We
learned this year that malfunctioning linear accelerators have
left patients nearly comatose and unable to speak, eat or walk.
Just last month, the New York Times reported on the
suffering caused by faulty metal-on-metal hip implants.
According to the Times, patients were promised these hips would
last longer and enable more activity. About half a million
patients got these devices. Now they are being recalled due to
high rates of failure and patients have suffered severe health
effects and have been forced to undergo surgery to replace the
defective devices.
And these are just the most recent examples. We have also
heard about problems with implantable heart devices that
shocked patients and led to at least 12 deaths. Implantable
defibrillators made by another company were failing for years
before the manufacturer told anyone.
Our focus in this committee should be on how we can
strengthen our device laws to protect patients from these
grievous harms. Yet I fear that this is not the committee's
goal today. Instead of strengthening our device laws,
Republican members have proposed radical changes to our device
laws that could further imperil patients. That is exactly the
wrong direction for us to take.
We will hear testimony today that FDA is imposing new
restrictions to innovation. Device industry advocates often
refer to two industry-funded reports, one conducted by Dr. Josh
Makower and one by the California Healthcare Institute, that
they say show that FDA is unduly slow, burdensome and
unpredictable. Yet neither of these studies, as Ms. DeGette
pointed out, was published in a peer-reviewed journal, and both
of these studies were funded by and conducted for industry
advocates. Because of the lack of independent validation of
these reports, I asked my staff to request that the editors of
our Nation's top medical journals, one of whom is a witness
today, examine the methodology of these two industry papers.
All three editors we asked agreed to participate.
As our witness will describe today, there are serious
methodological flaws in both studies--biased samples, small
sample size and botched statistical analysis, just to name a
few--rendering them essentially useless as part of any
discussion of FDA's regulatory system. None of the editors felt
that the methodology of these studies was worthy of publication
in a peer-reviewed journal.
We will also hear today from six witnesses who will express
their concerns that the FDA's device regulatory system is
depriving patients of new and potentially life-saving devices,
inhibiting innovation, and costing Americans jobs. FDA can and
should do better in many of these cases. But we can't legislate
by anecdote.
We need to ask why unsafe devices have gotten onto the
market and harmed so many patients. Then we need to explore how
we can strengthen the FDA review process to protect patients
from these risks. The soon-to-be-released recommendations from
the Institute of Medicine could provide a roadmap for how to
improve FDA's regulatory oversight of medical devices.
In order to have a flourishing and innovative American
device industry that puts safe and effective devices on the
market, we need to have a strong and well-resourced FDA. That
is in the best interest of American patients. It is also in the
interest of the device industry itself. If patients lose
confidence in the FDA, they lose confidence in the industries
it regulates as well.
This is an issue that can and should be bipartisan. I look
forward to hearing from our witnesses and to working with my
colleagues on this important matter.
[The prepared statement of Mr. Waxman follows:]

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Mr. Stearns. I thank the gentleman.
Let me say, we have seven witnesses, not six, and we
welcome all seven witnesses to our hearing, and I call
attention to the bio of each of these witnesses. If members
will take the time to read that, I won't have to go through all
seven.
Let me address all of you. You are aware that the committee
is holding an investigative hearing, and when doing so has the
practice of taking testimony under oath. Do any of you object
to taking testimony under oath? No? The chair then advises you
that under the rules of the House and the rules of the
committee, you are entitled to be advised by counsel. Do you
desire to be advised by counsel during your testimony today? In
that case, if you would please rise and raise your right hand,
I will swear you in.
[Witnesses sworn.]
Mr. Stearns. You are now under oath and subject to the
penalties set forth in Title XVIII, section 1001 of the United
States Code. We welcome your 5-minute opening statement, and
your written statement will be part of the record.
Dr. Fischell, we will start with you. Welcome.

TESTIMONY OF ROBERT E. FISCHELL, CHAIRMAN AND CEO, FISCHELL
BIOMEDICAL LLC; CAROL MURPHY, PATIENT; MARTI CONGER, PATIENT
AND PATIENT ADVOCATE; PAM K. SAGAN, PATIENT; MICHAEL MANDEL,
CHIEF ECONOMIC STRATEGIST, PROGRESSIVE POLICY INSTITUTE; SEAN
IANCHULEV, CHIEF MEDICAL OFFICER, TRANSCEND MEDICAL, INC.; AND
GREGORY D. CURFMAN, EXECUTIVE EDITOR, NEW ENGLAND JOURNAL OF
MEDICINE

TESTIMONY OF ROBERT E. FISCHELL

Mr. Fischell. Chairman Stearns, Ranking Member DeGette,
members of the subcommittee. My name is Robert Fischell, and I
am pleased to testify today about an issue of great importance
to me, to patients, to physicians and to the American public.
For more than four decades of my 82 years, I have dedicated
my life to inventing and developing novel medical technologies
including an implantable insulin pump for diabetics, heart
pacemakers, implantable defibrillators, and co-inventing about
10 million of the heart stents that have improved health and
saved lives of patients in the United States and throughout the
world. I have personally been the inventor or co-inventor on
more than 10 medical devices including a new external device
that is effective in eliminating the pain of migraine
headaches, which device is here in front of me on this table.
These technologies have also spurred tens of thousands of
jobs in this country and resulted in billions of dollars in
U.S. exports to other countries that value our American medical
devices. Unfortunately, the environment that exists at FDA's
Center for Devices and Radiological Health over the past few
years is the worst that I have experienced in my 42-year career
involving medical technologies.
Given the success I have enjoyed over the years, some might
ask why am bothering to testify today. It is certainly not in
pursuit of money. I have enough to live pretty well. I am here
today because of the millions of patients and physicians who
are searching for therapies to improve the human condition.
Unfortunately, it is not technology, science, ingenuity or the
economy that is standing in the way of success in developing
new medical technologies. In my opinion, it is today the FDA.
As a strong supporter of President Obama and his policies, that
is not easy for me to say.
Prior to 2008, CDRH division was demanding safety and
efficacy for the many new medical devices that I had invented.
At that time, they were reasonable in allowing clearance of
devices that showed safety and efficacy. CDRH demonstrated the
ability to properly weigh the benefits and risks of new medical
devices as part of the premarket review process. CDRH
leadership understood that medical devices may have some risks,
but corresponding benefits that patients realized with the
therapy they provided were worth the risk associated with such
devices.
Over the past few years, I have personally been aware of
many instances where product clearances were denied or
significantly delayed by CDRH when the patient benefit clearly
outweighed any potential risk to the patient. One example of
this is a device that I invented that relieves the pain of
migraine headache with no serious side effects, this device
right here. That device was not approved by CDRH even after the
clinical trial proved safety and efficacy. A somewhat trivial
example is a small plastic valve that I have in my hand that
could open or close to allow liquid to flow, and had its
approval delayed by over a year when it had already been
approved for regular use in other equipment.
The failure of the current CDRH to efficiently and
effectively review medical devices is a serious problem for the
citizens of the United States. Many published reports suggest
that patients are being forced to travel outside the United
States for therapies that were developed here. Even worse, many
patients do not have the resources to travel abroad and are
forced to suffer, waiting desperately for FDA to clear or
approve therapies that in some cases have already been
available for years outside the United States.
Beyond the adverse impact FDA is having on patient care, it
is weakening the U.S. leadership position in medical technology
innovation, and as a result, hurting our economy. As someone
who has enjoyed success in this industry, I have been proactive
in trying to assist the innovators, scientists and engineers of
tomorrow to be in this field. I recently established the
Fischell Department of Bioengineering and the Fischell
Institute for Medical Devices at the University of Maryland.
Today, I am truly concerned for those scientists, engineers and
innovators who study there who are about to embark on their
careers. If I were to be starting out today, I would likely be
unable to make the contribution to patients' lives that I have
made over the past 40-plus years because I would be unable to
raise the funding or endure the delays that exist with the
current regulatory environment at CDRH.
In dealing with the FDA today, the reviewers appear to be
slowing down or totally denying clearances for valuable medical
devices that would be of great benefit for patients in the
United States. By doing this, they are proud of being so
conservative. I mean, look how good I am, I am so conservative,
I am not even going to approve it. I am aware of examples where
reviewers have changed the requirements for companies during
the premarket review process with no credible evidence
supporting the moving goalposts.
One such example has recently occurred with a device that I
co-invented that improves the treatment for epilepsy using a
tiny electrical stimulator that I have here.
The inability for reviewers to be held accountable for
their changing standards and increased risk aversion is
something Congress and undoubtedly this committee must address
if we are to improve patient care in this country and promote
innovation and jumpstart our economy. While it may be difficult
to legislate culture and restore the collaborative, reasonable
and effective CDRH that existed back in 2008, I urge this
committee to try. Patients, physicians, innovators and the
American public are counting on you to step up and restore a
reasonable and predictable CDRH that appropriately balances
risks and benefits, works collaboratively with industry and
understands that unnecessarily denying----
Mr. Stearns. Dr. Fischell, I need you to summarize.
Mr. Fischell. Two sentences.
Mr. Stearns. Good. OK.
Mr. Fischell [continuing]. Access to medical therapy means
that FDA is failing in its primary mission, which is to protect
patients but also to allow clearance for devices to relieve
pain and suffering that many patients would otherwise have to
endure. Thank you.
[The prepared statement of Mr. Fischell follows:]

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Mr. Stearns. Ms. Murphy, welcome.

TESTIMONY OF CAROL MURPHY

Ms. Murphy. Thank you. Good morning. I am Carol Murphy.
I have been a migraine sufferer for 40 years. I have three
to four aura migraines a week. I have been through beta
blockers, antidepressants, anti-seizures, abortive medications.
When you have done that, you go on to the next step, so I have
had occipital blocks, I had steroidals, cervical blocks, I have
had Botox with minimum success.
At Michigan Head Pain and Neurological Clinic, once you
turn 60 years old, you don't fit any of the medical protocols
for migraine medicine and therefore they left me with the
narcotic oxycodone to take care of a migraine headache, and
that was it.
I finally got into the trial program at Ohio State with the
transcranial magnetic stimulator, TMS. I was told to put the
device on my head, activate it twice during an aura. When I did
that, the aura cycle kept going but at the end of the aura when
the pain should have started, it didn't. The blood vessels did
not fill up. There was no pain. There was no headache. For 9
months, I lived like a normal person, and then in June of 2006,
Ohio State took it back because it was going to go through the
FDA process for approval. Give us 9 months, give us a year,
Carol. Yes. It is now June of 2011--July of 2011. Where is my
machine? That is in England. That is not here. I can't get it
here.
A lot of people think that a migraine is a headache. It
isn't. When blood vessels swell in the brain, every part of
your body can be affected. For me, my feet and legs get so cold
that there is absolutely no way for me to sleep so going to bed
and sleeping it off doesn't work. And there is no way of
warming those legs until after the migraine stops. When I take
OxyContin, it dulls the pain but it doesn't break the migraine
cycle. With the TMS, no headache because the blood vessels
weren't dilated.
With migraines, I also experience urinary and bowel
problems. By the second day, I have abdominal pain. I also have
problems concentrating. The thoughts in my head are clear but
the words coming out of my mouth sometimes are not right or
they just don't come out at all. This doesn't happen with the
TMS because we don't have the dilation of the blood vessels.
As I get older, falling becomes a major problem for me, and
my left leg drags during a migraine. So I need to be more
careful. I need to have the good balance. And with the TMS,
again, we don't have the lagging of the left foot.
Now I live my life between a rock and a hard place. I can
take the medication, I can deal with the fact that it is
addictive or I can crawl up in my little hole and stay there
until it is over. Either way, that is not quality of life. I
want my device back. I will go to England to get it. I will rob
Peter to pay Paul to get there because for me, it is a quality-
of-life factor.
I want to look forward to a life without any pain. I want
to know that I am not going to wait until 3 or 4 or 5 years for
the FDA to turn around and approve this machine.
There are millions of migraine sufferers. Everyone has
their own story. I am one that medication just doesn't work
for. We as Americans should not have to go to England to get a
piece of machinery that I know that I used 5 years ago safely.
This is a product that was made in America, by Americans, but
obviously not for Americans. How long do we have to wait? Five
years is a long time. How many more years? How many more
migraines am I going to go through if I am going to sit and
wait for the FDA to approve this product?
Thank you for your consideration and time.
[The prepared statement of Ms. Murphy follows:]

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Mr. Stearns. Ms. Murphy, that is very compelling. Thank
you.
Ms. Conger, you are recognized for 5 minutes.

TESTIMONY OF MARTI CONGER

Ms. Conger. And I timed the 5 minutes, practicing on the
airplane.
Hello, and I thank you very much for the invitation to
testify. I am a spine patient and a very angry one. I became
livid when I figured out that my government was the main
barrier between me and the best solution for my spine problem.
I am here today as an advocate for the millions of U.S.
patients like me who are needlessly suffering, deteriorating
and sometimes dying while they wait for the FDA to approve
medical devices they desperately need, devices that are often
already in successful use in other countries.
Briefly, a little about me. My TOS specialist identified my
cervical spine issue in 2006 and quickly sent me to University
of California San Francisco Spine Clinic to Dr. Dean Child, who
had been involved in cervical spine artificial disc trials,
clinical trials.
Now, I have been dealing with multiple life-altering health
issues, and since I can't take narcotics or opiates, I was
already physically and mentally drained from chronic pain and
raging paresthesia. If you want to imagine that, just walk
around barefooted on a bristle brush, and that is paresthesia
in your feet.
My neurosurgeon's--my surgeon's diagnosis just had me
reeling. What else can go wrong? I already had this long list
of deals. But he immediately started educating me. After he
reviewed my films in detail, we discussed my options, the
benefits and consequences, and in my case, my choices were,
first, do nothing, wait for quadriplegia in the next couple of
years, or have fusions, which I later learned meant I would
likely have chronic pain in my neck and possibly have cervical
fusion in the future. The third choice, wait a couple of months
for an artificial cervical disc in the FDA approval pipeline,
one widely used and successfully in Europe since 2003.
While I waited for device approval, my spine degenerated to
the point that my doctor and I feared I was in serious danger.
All my limbs were numb. My continence was an issue. My balance
and my grip were unreliable. I was a prisoner in my own house
for fear of going outside and having a paralyzing accident, and
I depended on everyone else to take care of my needs. I knew I
couldn't living this way safely but I was not having fusions.
Nor could I believe the newer clinical cervical device
technology which my doctor and I felt was best for my problems
were made 40 miles south of my house and I could not get them
installed in my Nation. Forty miles from my house. By the way,
those jobs have disappeared to Europe because European
countries will sometimes say, if you don't have approval in the
United States or your home country, country of manufacture, you
can't sell them here. So they moved all those jobs, those
$160,000 to $100,000 jobs to Germany. Yet these devices were in
successful use in Europe and elsewhere.
My only option to get the best solution for me was for me
to go abroad. It took research and months of fundraising. We
drained our savings, what little we had. We accepted $5,000 in
gifts from friends and family. I stripped my life insurance
policy of cash value. We incurred credit card debt, and my 75-
year-old husband had to return to full time, and he has been
working since.
Finally, I had my two-level ADR surgery in 2009 at the
Spine Clinic in England. My pain relief was immediate, and my
discs are functioning flawlessly. My U.S. neurosurgeon is
delighted. He does my follow-up.
And what about all the other--so I got the best solution
for me but it shouldn't have taken all my limited energy and
money to get them. What about all the other Marti Congers in
this country, people waiting for access to medical devices that
already have foreign approvals and years of track record. I
know, because I receive calls and emails every week from spine
patients from auto mechanics to engineers to cardiac surgeons.
They want to know how they might get the treatment they need
somewhere, somehow, because they are not going to do the
procedure here. And what about all the other devices common in
Europe and in Asia but bogged down in the FDA process. Products
often invented here aren't available to U.S. patients for years
after patients around the world already have them. It simply
shouldn't be this way. It shouldn't.
I do appreciate, Mr. Stearns, that the agencies' challenges
that they face right now from all directions. I appreciate
their desire to protect people. However, our FDA needs to
restart, reset their priorities back to patients' needs and
away from political risk aversion. Patients are looking for
reasonable assurance and timely approval or denial--not all
devices make it--but absolute assurance, what seems to be the
goal here, is impossible, impossible, because every human body
is unique.
For products with strong track records, the FDA should
leverage regulatory findings from other trusted countries and
unions such as Japan, Australia, European Union and others, and
put them into the marketplace or at a minimum fast-track them,
then monitor--oK. Two sentences?
Mr. Stearns. Just if you could wrap up.
Ms. Conger. Yes. Monitor them in the marketplace. Requiring
known devices to restart the approval process from the
beginning when thousands of human already have them in their
body is ludicrous. The sooner we act on these changes, the
sooner U.S. patients will have access to the devices they need
at a reasonable price instead of waiting 2 to 10 years to get
the device here.
[The prepared statement of Ms. Conger follows:]

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Mr. Stearns. I thank the gentlelady.
Ms. Sagan, you are recognized for 5 minutes. I just urge
everybody if possible to keep it to 5 minutes.

TESTIMONY OF PAM K. SAGAN

Ms. Sagan. Chairman Stearns, Ranking Member DeGette and
members of the committee, thank you for asking me to testify
before you today.
My husband and I have three children, the youngest of whom,
our daughter Piper, was diagnosed with type 1 diabetes at the
age of 2 in 1989. She has lived over 20 years with this
constant, frightening, deceptive and malicious disease.
I come before you today not only as a parent but as an
advocate for tools and technology for my daughter and others
with diabetes and with my enduring hope for a cure.
Piper has always been prone to hypoglycemic events--low
blood sugar. They seem to come on hard and fast. I remember her
almost drowning as a youngster after becoming unconscious from
low blood sugar while taking a bath. College also brought one
or two incidents a year where she slept into hypoglycemia and
didn't wake up the next morning, requiring emergency medical
care.
There is a chilling term that is the worry of every parent
of a child with diabetes called ``dead in bed.'' Kids are found
dead in the morning after a completely normal evening the night
before. Most of the time it is due to severe hypoglycemia. I
don't want this to happen to my daughter or anyone else with
diabetes, so you can understand where my fire comes from.
Just this past winter, Piper, now a 24-year old, had
another severe hypoglycemic event. While working at a retail
store, the last thing she remembers is closing the front door
of the shop as she left to walk the 10 blocks to her apartment.
My cell phone rang at home, and she slurred to me that she was
locked out of her apartment. Upon further conversation, I
realized that she was low. She had wandered her way home in a
semiconscious state. She had crossed busy San Francisco city
intersections at rush hour, she had fallen and scraped her
hands as she walked, and she had lost bladder control. She
finally ended up at her apartment, the keys were in her purse,
but she didn't know what they were. She pulled out her cell
phone and pushed the number one, my cell phone number. All this
time, her continuous glucose monitor was alarming, but her
blood sugar was too low to take action, and her insulin pump
continued to pump insulin into her body, lowering her blood
sugar even more.
This is life with type 1 diabetes. Type 1 diabetes occurs
when the body's immune system attacks the cells in the pancreas
that produce insulin. Insulin regulates glucose in one's body,
and without it, a person with type 1 diabetes cannot live.
There is no cure for this disease and it imposes an enormous
physical, emotional and financial burden. On average, a child
with diabetes will have to take over 50,000 insulin shots or
infusions in a lifetime. Every hour of every day for the rest
of her life, she will have to balance insulin, food and
activity to try to prevent low and high blood sugars, and the
devastating and costly complications: seizures, comas, kidney
failure, heart disease, blindness and amputations. It astounds
me that diabetes costs our nation more than $174 billion a year
and one in three Medicare dollars is spent to care for people
with diabetes.
Because of these burdens, people with diabetes and their
loved ones need timely access to innovative, life-saving
technologies to help better manage the disease. Some
breakthrough tools and technologies that protect against
dangerous diabetes episodes are already available all over the
world, but not available here in the United States.
I don't claim to be an expert on the regulatory process at
the U.S. Food and Drug Administration, but as a parent with a
daughter with diabetes, I am extremely frustrated that better
technologies to help people with diabetes are delayed here in
the United States. Low-glucose suspend systems have been
approved for nearly 3 years and used safely in over 40
countries worldwide, but they are not available here in
America. This technology is one critical example where our
Nation is lagging behind in the approval of devices that would
make living with this disease much safer. As background, these
pumps stop delivering insulin automatically when a monitor
indicates that the body's glucose levels are low. With this
kind of pump, my daughter wouldn't receive more insulin when
she is already low, causing her blood sugar to drop further and
potentially causing a seizure, coma and even death. With the
present FDA approval process, it will require a clinical trial
conducted in this country, and a delay of years to conduct the
study and compile the data before a decision is made. Kids are
dying from hypoglycemia now. I want, and my daughter needs,
this system available in the United States today.
In 2006, I was thrilled that the FDA recognized the
importance of this technology and placed the artificial
pancreas on its Critical Path Initiative. That was 5 years ago.
With the funding from the Special Diabetes Program, for which I
am so grateful to all the members of this committee for
supporting, the artificial pancreas was tested favorably in a
hospital setting. Now it is time to move to outpatient studies.
I implore Congress to continue to urge the FDA to move
forward on next steps relating to low-glucose suspend systems
and the artificial pancreas so that people with diabetes will
remain healthier and safer until a cure is found, and I would
lead the chorus of applause for the FDA when real progress
happens, but it has to happen very soon. My daughter's life is
depending on it.
[The prepared statement of Ms. Sagan follows:]

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Mr. Stearns. Thank you.
Mr. Mandel, you are recognized for 5 minutes.

TESTIMONY OF MICHAEL MANDEL

Mr. Mandel. Members of the subcommittee, thank you very
much for the opportunity to testify on medical device
regulation and its impact on health and innovation.
This statement draws heavily on a recent policy brief that
I wrote for the Progressive Policy Institute where I am chief
economic strategist. I am going to talk about one specific
example where the FDA is apparently impeding innovation. I will
then briefly discuss what we can do to boost innovation without
hurting health and safety while expanding high-quality health
care to underserved populations.
My major focus as an economist is the link between
innovation and jobs. U.S. job growth has been weak since 2000.
Surprisingly, innovation has been weak as well once we look
beyond IT and communications. We got the iPhone but we didn't
get gene therapy. We got Angry Birds but we didn't get enough
health-improving, productivity-enhancing medical technologies.
The question is why. There are plenty of culprits. Profit-
seeking companies, inflexible doctors, out-of-control lawyers,
myopic academics, the list could go on and on. But today I am
going to focus on the FDA.
The FDA has a very tough and essential job: ensuring the
health and safety of the American public. But over the years,
people have regularly complained to me that the FDA imposes
excessive requirements on the approval of new drugs and
devices. No doubt the FDA has gotten stricter in recent years
about requiring evidence of safety and effectiveness. However,
by itself, that is not enough to show over-regulation. Health
and safety is paramount, and no one wants dangerous drugs and
devices put on the market. It could be that we were under-
regulating before. However, in May 2011, I heard about one
example that suggested over-regulation. This was MelaFind, a
name that I had never heard before, a handheld computer vision
device intended to help dermatologists decide which suspicious
moles and spots should be biopsied for melanoma.
Not to go into detail here, but if MelaFind worked, it was
easy to see how it could improve health and cut costs.
Moreover, MelaFind could be used to augment care in low-income
and rural areas. Equally important, the device was non-
invasive. That meant it was as safe as possible, and it was an
IT-driven expert system, which meant that it would get better
over time as the computer power increased. Imagine my surprise
when I discovered that the FDA staff had deemed MelaFind not
approvable, and double my surprise when I read the briefing
document that the FDA staff prepared for a panel of
dermatologists, statisticians and other experts who were voting
on whether to recommend MelaFind for approval. The FDA briefing
document started with a very reasonable analysis of the
shortcomings of the MelaFind test results. I was initially
quite sympathetic to FDA's perspective but when the FDA started
listing its broader objection to MelaFind and what it expected
the device to do, it quickly became clear that the agency was
using a set of standards that no first-generation device could
ever reach.
Just a couple of striking ones. The FDA objected because
the study did not find ``a clinically significant difference
between MelaFind and the examining dermatologist.'' The agency
also objected because the device was not demonstrated to make
inexperienced doctors the equal of experienced dermatologists.
Let me repeat that. The FDA apparently was saying that in order
to be approved, that MelaFind had to beat experienced
dermatologists and had to turn inexperienced doctors into the
equivalent of board-certified dermatologists. These are great
goals. These are fantastic goals. However, they are also goals
that no first-generation device can ever reach. Failing to
approve MelaFind is the equivalent of rejecting the first cell
phone on the grounds that callers might mishear important
emergency messages. Or think about a government body telling
Steve Jobs in 1977 that the first Apple computer was not
approvable because he had not submitted a study showing Apple
users could be trained to produce the same results as users of
mainframe computers.
Because MelaFind is non-invasive, it gives us a clear
window into the FDA's approach that we don't get from other
devices and drugs that may have negative side effects. As an
economist, it worries me that we are missing health-improving,
productivity-enhancing devices and drugs because the FDA has
too narrow a perspective. Thank you.
[The prepared statement of Mr. Mandel follows:]

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Mr. Stearns. Thank you.
Dr. Ianchulev, you are recognized for 5 minutes.

TESTIMONY OF SEAN IANCHULEV

Mr. Ianchulev. Thank you. Mr. Chairman, Ranking Member
DeGette and members of the subcommittee, I am Dr. Ianchulev,
and I would like to thank you for the opportunity to share my
personal experience with the FDA and the regulatory process and
its impact on patient care, innovation and development of new
technologies in this country. These are my own opinions, and I
share them to you from the perspective of a physician,
innovator and developer of some new therapeutics and devices.
In the way of background, I am a physician, eye surgeon who
uses medical devices and technology to treat and prevent
blindness. I am an associate clinical professor on the faculty
of UCSF School of Medicine, where I see firsthand the
translation of research into patient care, and as the developer
and inventor of new technologies in the field, I have led
innovative treatments through the regulatory process with the
FDA and I have direct experience with the drug and device side
of the FDA in addition to experience with the European
regulatory authorities.
Physicians such as myself feel privileged to be educated,
practice and advance medicine in the United States. The United
States has been a leader in cutting-edge innovation
traditionally, and my field, ophthalmology, is a bright example
to that effect. In fact, the most common device implanted today
is the intraocular lens implant for cataracts, and this has
been one of the most successful, effective and safe treatments
to date based on innovation of the 1980s and 1990s and based on
leadership of the FDA at that time with a streamlined
regulatory process.
Today more than ever, we need best-in-class technology in
service to our aging population and it is unfortunate that
patients are starting to seek care from foreign doctors who are
now trained and have hands-on experience with technologies we
see much later in the United States, as we heard today. As a
physician who not only delivers the standard of care but also
innovates in my field, I have failed a number of times to treat
patients with what I think is the best treatment for them. In
fact, I see more and more patients seeking the often-
challenging offshore route in search of interventions that are
not available here with much added cost, frustration and pain.
When recently asked by a patient suffering from a degenerative,
blinding eye disease about a therapy not approved in the United
States but available in other countries, I had to stay silent.
The patient ended up traveling to Canada to receive treatment
for which he paid out of pocket.
But I would like to go beyond the anecdotal experience and
ask the bigger question: what innovative first-class therapies
are we delivering to patients today? Let us take the field of
ophthalmology, which is a good example with its high degree of
technical innovation and device utilization. To check the
innovation pulse prior to this hearing on the way here, I
reviewed all of the FDA-approved PMA devices in my field over
the past 5 years. As you aware, the PMA class III devices is
the lifeblood of innovation and some of the most advanced,
complex devices for life-sustaining or, in my case, vision-
sustaining, treatments are approved through this process. I
reviewed the labels of all 12 such devices I could find on the
FDA Web site. At the time of approval, all of them had been
approved not only in the EU but in many as 20 to 40 countries
before they were approved in the United States. In addition,
some of the devices already had vast clinical experience
dwarfing the FDA clinical trial numbers and in some examples
those were more than 100,000 patients treated worldwide before
FDA approval. In one illustrative case with the cumulative
world experience of more than 60,000 patients, the FDA label
spoke only of 300 patients in the registration trials, too few
and too late.
Avoiding a long discourse on the meaning of the symptomatic
state, it is not hard to see that we have failed to deliver
best-in-class innovation. More importantly, we now see that new
technologies are not only perfected abroad but are developed
and commercialized to their full extent and companies now
execute not only on small feasibility studies but implement
their main validation studies, their clinical research programs
and even product launches abroad, as evidenced by a recent MDVC
report. What follows with that is the departure of talent,
expertise and patients.
The FDA is the gateway for new therapies, and as a vigilant
gatekeeper, the regulatory process has to ensure safety and
efficacy, but it has to facilitate innovation, and examples of
that are right in the halls of the FDA. As a drug developer who
headed the clinical research and development programs at one of
the most successful approved biologic therapies for eye
disease, Lucentis for macular degeneration, I have added
comparative experience from the CDER, whose input and oversight
were critical in the execution of this highly complex, rigorous
therapeutic program of biologics and resulted in the
commercialization of a groundbreaking therapeutic which helps
hundreds of thousands of patients today.
So this program was not only successful but exemplary in
many ways of how the regulatory process should work and was
referenced by the FDA itself in a published guidance to
industry for best-in-class drug development. The key learnings
from this experience--explicit guidance to companies and
investigators, consistency and transparency of feedback in the
review process, and a high level of in-house expertise from the
FDA reviewers.
My experience with the development of new technologies is
that the pathway to innovation is challenging and it is
necessary to take calculated risks in a thoughtful and
deliberate way and to protect patients. We need safe and
effective treatment for all patients and it is critical that we
have the best-in-class regulatory process to do justice to the
high level of passion, hope, talent and resources this country
invests in the innovation process in helping patients. Thank
you.
[The prepared statement of Mr. Ianchulev follows:]

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Mr. Stearns. Thank you.
Dr. Curfman, you are recognized for 5 minutes.

TESTIMONY OF GREGORY D. CURFMAN

Mr. Curfman. Thank you, Chairman Stearns, Ranking Member
DeGette and other distinguished members of the subcommittee. My
name is Gregory Curfman. I am a cardiologist and I am the
Executive Editor of the New England Journal of Medicine.
For nearly 200 years, the New England Journal of Medicine
has been publishing research articles on new drugs and medical
devices. We are strongly committed to innovation. Vigorous
innovation in medical products is critical to the health of our
Nation. But we have learned that innovation in medical
treatments does not come easily. While some new drugs and
devices succeed, others unfortunately fail, in many cases,
owing to serious problems with safety. Innovation is essential
to the future of our Nation but innovative medical products
cannot succeed unless they are both effective and safe.
Sensible quality assurance does not stifle innovation, it
promotes it and avoids costly nightmare scenarios caused by
flawed and potentially dangerous medical devices.
Let me give two recent examples of innovative medical
devices, one from the field of cardiology and the other from
the field of orthopedic surgery, both of which were approved by
the FDA by the 510(k) fast-track process, but which were later
found to be seriously defective even while they were being
implanted in many thousands of patients.
The first example, from the field of cardiology, is the
Sprint Fidelis implantable cardioverter-defibrillator lead,
which was manufactured by Medtronic. This lead, which delivered
an electric shock to the heart in order to halt potentially
fatal heart rhythms, was approved by the FDA by the 510(k)
process without clinical testing. The defibrillator lead
received considerable hype as a major innovation in
defibrillator technology. However, soon after fast-track
approval of the Sprint Fidelis, it became clear that the lead
was prone to fracture, which resulted in inappropriate shocks
in many patients and caused at least 13 deaths. The lead was
eventually withdrawn, but only after it had been implanted in
over a quarter of a million patients worldwide. Thus,
inadequate premarket testing and a fast track to FDA approval,
resulted in a devastating situation for patients.
The second example, from the field of orthopedic surgery,
and Congressman Waxman referred to this earlier, is a type of
artificial hip implant known as the metal-on-metal design. Hip
implants originally consisted of a metal ball inserted into a
plastic cup. In newer models, which were widely hyped as a
major technological innovation, the plastic was replaced with a
metal alloy, the so-called metal-on-metal design. The new
design was approved by the 510(k) fast-track process and did
not undergo clinical testing, only bench testing. Not long
after FDA approval, reports of shedding of metallic debris and
failure of the metal-on-metal implants began to surface, and
upwards of tens of thousands of patients have thus far been
adversely affected.
Unfortunately, bench testing of the device did not
faithfully reproduce the wear and tear of real life. Thus, an
apparently minor alteration in design--replacement of plastic
with a metal alloy--resulted in nothing short of a public
health nightmare.
These are sophisticated engineering devices that we are
talking about. These two examples vividly demonstrate that the
glamour of innovation does not always work out well for
patients. Innovation in medical devices must go hand in hand
with a careful assessment their efficacy and safety. Such
quality control measures do not imperil innovation; they
advance it, they secure it.
As for the European Union, the timelines to device approval
there are only modestly shorter than in the United States, and
it is of concern that in Europe, in contrast to the United
States, the highest risk-devices, so-called class III devices,
do not have to be shown to improve clinical outcomes prior to
their approval. That is something to think about.
Mr. Chairman, innovation in medical devices is a high
priority for our Nation, but to be truly innovative and to
avoid costly mistakes, there must be solid evidence that new
medical devices are both effective and safe. Thank you, Mr.
Chairman.
[The prepared statement of Mr. Curfman follows:]

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Mr. Stearns. I thank you, and I thank all our witnesses.
Dr. Ianchulev, you mentioned a capital report in your
testimony. Do you mind submitting it for the record?
Mr. Ianchulev. I have it here.
Mr. Stearns. OK. That would be fine.
Let me start by asking my questions. Dr. Fischell, I will
start with you. Your resum obviously is very impressive. You
are a physicist, an inventor. It says you have over 200 U.S.
and foreign medical patents. At one time you were honored as
inventor of the year in the United States, so you do have a
high degree of credibility. So my question to you is, you state
in your testimony that the environment that exists today at the
FDA device center over the past few years, you specifically
pointed out, is the worst that you have experienced in 42
years. Now, that is a pretty strong, dramatic statement. Can
you give us specifics why you think that is true?
Mr. Fischell. There is a new attitude of the reviewers at
the FDA. They are very proud to be conservative. Conservative
says oh, I am going to throw it back, I won't approve it,
therefore, I am protecting the American people from potential
harm, and in some cases, they should have. One of the problems
is that the reviewers are not expert in the field. For example,
with our migraine device, we proved in clinical trial it cured
migraine, it cured sensitivity to light and sound, but we
didn't reach the 95 percent certainty for nausea, only 88
percent certainty. They said it is therefore not approvable for
pain, for migraine, which it cured in an excellent way. So I
think it is this conservativeness that the people have that is
encouraged and say oh, you are really a good guy, and to me,
that is the main problem. I think we need more expertise at the
reviewer level. We have a medical advisory board of eight
leading migraine doctors in the world who go to the FDA and say
what should be approved. The person there is a couple months
out of college with no training in migraine and they stop it.
Mr. Stearns. Dr. Shuren is here in the audience, and I want
to compliment him for staying and listening here. Normally
sometimes the Administration speaks first. He was very
confident and conscientious enough to say he would listen to
you, so I think that is a credit to him, and I want to
compliment him for staying and listening. Oftentimes the
Administration comes over and speaks and they are out the door.
So it is a compliment to him for staying here.
But let us I put you in charge of FDA tomorrow, oK? What
would you do different or what would you tell Dr. Shuren that
you would suddenly create this new environment that would give
the United States the answer to some of these problems that our
witnesses have said?
Mr. Fischell. I would--I have carefully thought about this
and the problems that Congressman Waxman has raised, and what I
think should be done is, when a 510(k), for example, goes to
the FDA, the reviewer then should seek like three experts in
that field to review the clinical trials suggested, and when
that clinical trial is done, to review the results so that it
is reviewed by people expert in the field, not just a reviewer
with no experience in that field. I think that would change
safety and efficacy.
Mr. Stearns. So the bottom line is that people that are
making these decisions don't have the confidence, in your
opinion?
Mr. Fischell. I was with Commissioner Hamburg just a couple
of weeks ago, who said they have a lot of trouble with
retaining people and what have you, and I think that the FDA
could easily call upon within a week of submission experts in
the field like three experts in leads for defibrillators, and
say please review this because you have spent 10 years of your
life on it, I have never heard of it before. Does it not seem
obvious that those who are expert in the field should be
reviewers, not a person who happens to be there?
Mr. Stearns. But it is interesting, you are saying that in
your 42 years of experience, you have never seen it as recent
in the last couple years like it is today, so your complaint is
very serious on criticism of the present FDA right now.
Mr. Fischell. I think there is a different attitude there
than we have seen before.
Mr. Stearns. Thank you for saying that.
Dr. Ianchulev, Dr. Shuren, who is behind you, mentions in
his testimony that poor submission quality is a big reason
behind the sharp increase in review times we have seen in the
past 7 years. That is going to be his case. Now, you have a lot
of experience in submitting device applications to the center.
Do you agree with his assessment?
Mr. Ianchulev. Yes. I can make a comment on that. It is
always hard to be self-critical. I am sure my submissions can
probably be better, but a couple of observations that I have
realized working on that front in the trenches. Very often, as
we know, companies that operate in the device space especially
and it is slightly different in the drug space with the big
pharmaceuticals are smaller companies, companies that have
fewer than 50 employees, so one can imagine that they don't
have always in-house expertise and specialization. But at the
same time, a lot of them outsource all of their regulatory
processes, especially today when they are so challenged and so
complex, they outsource it to regulatory experts, and in my
experience, that has been usually the way of submissions to the
FDA to go through an outside consultant or expert with usually
20-plus years of regulatory experience. So I really can't
comment to every submission. I am sure that they have better
visibility to that but I can imagine that that expertise on the
consulting firm has not changed.
And then also, I think that is a good point because it
would be really nice to see best-in-class examples of
submissions where the agency proactively can give that guidance
if they are concerned about the status and quality of those
submissions, that people that work with them can see what the
expectations are up front, see good examples of good
submissions and really adjust their practices.
Mr. Stearns. I thank the gentleman. My time is expired.
The gentlelady from Colorado, Ms. DeGette, the ranking
member, is recognized for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman. I want to
thank all the witnesses for coming today and particularly the
three patient advocates who have come their stories.
I just want to clarify with all three of you. Your stories
are all compelling and they touch all of us because we all have
relatives or friends in the same situation. By talking about
how these devices could be brought to market and help you or
your families, none of you are saying that you would sacrifice
safety or thoroughness of review, correct? Ms. Murphy, you're
not saying you would sacrifice safety or thoroughness of
review?
Ms. Murphy. No, I am not.
Ms. DeGette. And Ms. Conger?
Ms. Conger. Safety and what?
Ms. DeGette. And thoroughness of review to make sure that
it is safe.
Ms. Conger. Within reasonable.
Ms. DeGette. Right. Ms. Sagan?
Ms. Sagan. Absolutely.
Ms. DeGette. You would not sacrifice----
Ms. Sagan. I would not sacrifice safety.
Ms. DeGette. And Dr. Fischell, you are not saying that
either. You think that these devices should be safe, correct?
Mr. Fischell. Absolutely, but it should be done in a timely
manner.
Ms. DeGette. In a timely and efficient manner.
Now, Dr. Fischell, I don't know if you were aware, you are
an inventor and you submit these devices to the FDA. Now, the
budget that was passed by the Republican majority in the House
two times this spring cut the FDA's funding by about $241
million. So if we are going to hope to be able to hire experts
to review these applications quickly and to have the expertise,
do you think that a substantial cut in the FDA budget would
assist us in being able to expedite these reviews?
Mr. Fischell. I am sure that every company involved
including about six companies I am involved with would be happy
to pay for the fees paid to such experts to do the job in a
prompt way.
Ms. DeGette. Right, but certainly budget cuts is not going
to help us, is it?
Mr. Fischell. No, but the budget--this would not increase
the budget.
Ms. DeGette. Right.
Mr. Fischell. It would be paid for by the----
Ms. DeGette. OK. I actually kind of agree with that.
Let me ask you, Ms. Sagan, because you mentioned the
Special Diabetes Program, which makes funds available for type
1 diabetics and also American Indian populations, and last year
we reauthorized that. As you said, a lot of those funds are
going toward clinical trials for the artificial pancreas. Now,
just so you know, we sent that letter that I mentioned that
almost all the members of this subcommittee including the
chairman signed asking about quick approval of the artificial
pancreas, and also I spoke with Commissioner Hamburg about this
issue of the low blood glucose, and I am pleased to tell you
that we got a quick response to that letter in June and the FDA
issued a guidance on that low blood glucose monitor stopping,
so we can move forward on these things and we do have hope that
we will move quickly.
But from your perspective and from your daughter's
perspective, I know you probably agree, we don't want to
approve an artificial pancreas if it is going to be defective
because it could kill the patients, right?
Ms. Sagan. Yes.
Ms. DeGette. So we want to make sure it is going to work.
Ms. Sagan. Yes, we do.
Ms. DeGette. Yes. And that is kind of the same way I feel
too. So I guess I wanted to ask you, what is your perspective
as an advocate of how the FDA should balance the safety with
the speed in approval that we need for these medical devices?
Ms. Sagan. Well, in terms of the low-glucose suspend, I
don't think there is an issue with safety.
Ms. DeGette. I agree with you on that, but in general----
Ms. Sagan. In general, if--I mean, I believe that there
should be clear guidance documents and a decision made in a
timely manner. If it is a 90-day period, it should be 90 days,
and it shouldn't be further delayed after that. We have to have
safety and we are so ready to go to outpatient clinical trials
with artificial pancreas. We have done all the inpatient
clinical trials.
Ms. DeGette. Now, Dr. Curfman, I just want to finish with
you because you heard all of these stories, and in your job you
do all the time. What can be done to make sure that we expedite
safe and efficacious devices but at the same do the thorough
reviews that we need? Is there something that can be improved
at the FDA right now to do that?
Mr. Curfman. We are looking for a balance. It has to be a
balanced approach. On the one hand, we want to speed innovation
to patients, absolutely. On the other hand, we want to be sure
that the devices work, that they actually improve human health
and that they are safe.
Ms. DeGette. Do you think there is any problem at the FDA
right now?
Mr. Curfman. I think that there are two things that I would
look at at the FDA. Number one, I do think that the 510(k)
process needs to be looked at. I think there are issues there.
Some devices are being looked at under the 510(k) that probably
shouldn't be. On the other hand, there are also inefficiencies
in the process that are slowing down approval in some cases. My
sense is that it has gotten better but I think that more work
can be done to make it a more efficient process.
Ms. DeGette. Thank you very much.
Mr. Burgess. [Presiding] I thank the gentlelady for
yielding.
Dr. Fischell and Dr. Curfman, let me just be sure I have
some of my facts straight. Dr. Fischell, do I understand that
you are affiliated with Johns Hopkins University?
Mr. Fischell. I worked at the Johns Hopkins University for
30 years and was on the medical faculty as well as working as a
physicist at the Applied Physics Lab.
Mr. Burgess. So an academic at Johns Hopkins?
Mr. Fischell. Yes.
Mr. Burgess. And Dr. Curfman, are you at Mass General?
Where is your hospital affiliation?
Mr. Curfman. Yes, at Mass General Hospital and Harvard
Medical School.
Mr. Burgess. So just on the face of it, it seems like the
two of you are terribly similar. It appears as if your politics
are similar, you are both academics at big Eastern facilities,
and yet your conclusions are significantly different, at least
as I perceive on the panel today. You are shaking your head no,
you feel exactly as Dr. Fischell does. Is the difference
because he is an innovator and you are a reviewer? I know in my
days in medicine, we used to regard that there were two types
of doctors. There are thinking doctors and there are doing
doctors. As an OB/GYN, I was a doing doctor, all kinds of
things we did in our practice, but I didn't think very much. So
you are the thinking doctor here, and Dr. Fischell is the doing
doctor. Is that the difference here?
Mr. Curfman. No, I think we are really on the same page but
innovation requires two things. It requires fresh ideas, new
ideas, interesting new approaches, but it also requires careful
testing to be sure that the device works.
Mr. Burgess. And I don't disagree with that. I want to get
back to the 510(k) process in a minute, but Dr. Fischell, you
said something that I just thought was so important. I mean, in
this committee in 2007, we reauthorized the user fees for both
the prescription drugs and medical devices here in this
committee, and one of the big fights that we had that I lost
was over the people that make up these advisory panels to the
FDA, and at that time, of course, Republicans were not in
charge and that is why I lost, but the pendulum swung so far
that we cannot have anyone on a review panel that might have
any appearance of a conflict of interest, and as a consequence,
we excluded the universe of people who actually had some idea
about what these products did. So in retrospect, I guess what I
am trying to get you to say that I was right with those
amendments that were defeated, but can you speak to that for
just a moment? Because you were on that path a moment ago.
Mr. Fischell. Yes.
Mr. Burgess. And I want former Chairman Waxman, Ranking
Member Waxman to hear this.
Mr. Fischell. Well, there is always----
Mr. Burgess. So start out with ``Dr. Burgess, you were
correct.''
Mr. Fischell. Yes, I do believe you are correct, and even
though I am a very good friend of Congressman Waxman, and it is
a matter of, there is an old saying, you can either have
somebody who is expert in it and they--or someone who has never
worked in the field, and if you have someone who has no
knowledge of the field, that doesn't work very well. And so you
need people who really have knowledge in that field, and also
the FDA seems to be exceedingly slow. They don't even follow
their own guidelines. For example also, in this device for
migraine, there is no predicate device. We invented something
new. And so we had to go to a 510 de novo 510(k). To get a de
novo 510(k), you must first say to the FDA that we cannot
find--no, we first suggest devices that could be predicate
devices. We knew there were none. And they said you are wrong,
there are none. We say it is de novo. They said oh, oK, then it
can be de novo. You cannot go to the FDA and say it is a de
novo device.
Mr. Burgess. Do you think----
Mr. Fischell. That cost us several months at the beginning.
Mr. Burgess. Do you think you got good advice from the FDA
about what they would need to see from you to get this device
approved in a reasonable period of time?
Mr. Fischell. No. We wanted to cure migraine headache. They
needed us to cure photophobia, phonophobia and nausea with a 95
percent certainty.
Mr. Burgess. Let me ask you a question on the nausea.
Mr. Fischell. We got 95 percent on two of them but only 88
percent in nausea and they therefore said, I will never forget
the words, it is not approvable.
Mr. Burgess. On the nausea question, does a placebo score
an 88 percent if you----
Mr. Fischell. No, no, no. We were much better than the
placebo but so few patients had nausea that we didn't get the
statistic.
Mr. Burgess. And this is a noninvasive device?
Mr. Fischell. Correct, and not only that----
Mr. Burgess. You don't have to open anyone's head and put
anything inside?
Mr. Fischell. A prior device made by Neuronetics for
depression has 20 percent stronger magnetic pulse and 30,000
times more pulses. It is approved and working by the prior FDA.
Even though we were a tiny fraction of that, we could not gain
approval.
Mr. Burgess. Let me just, Mr. Mandel, if I could, just ask
you briefly on the MelaFind. In the continuum of things that
are approved, where does MelaFind fall? Is it a reasonable
device for a practicing physician to have in their hands?
Mr. Mandel. I think the company is intending it to be an
adjunct for dermatologists, so I think you have to distinguish
between the first-generation device, which would be restricted,
I think, to experts with a lot of savvy, and then the company
wouldn't say this but I would, if you kind of look down the
path future in the future, you could see how the improvements
would enable that it could be more used more broadly than that,
and when I think about what is being lost right now, it is not
only the device as it exists but it is the future as well.
Mr. Burgess. Well, I would just say from the perspective of
somebody who used to practice general OB/GYN, to have a device,
we are told we must do skin screenings every year when a
patient comes in for a visit to have something that could help
us determine, rather than just sending everything back to the
dermatologist or off to the dermatologist to be biopsied at
great cost, something to help us discriminate a little bit
finer because not all of us remember what we learned in medical
school about the irregular borders, the degree of coloration.
Mr. Mandel. The FDA says it wants to have a device. The FDA
says that it wants the device to be able to do that, to be able
to help an inexperienced doctor, but there is no way to get
from here to there without the steps in between. It is like
asking--it is like refusing to approval the initial cell phone
until you can have an iPhone first.
Mr. Burgess. I understand. Well, I thank you, and I will
yield back my time and yield to Mr. Waxman for questions.
Mr. Waxman. Thank you very much. Thank you all. As
witnesses, you have been very compelling in your stories and
your experiences, and all of us want to see these things move
faster. We want to get those therapies to those who need it.
The question that comes to my mind, the proposals that would
weaken the standards for the Food and Drug Administration, I
think a lot of the problem, and I look forward to hearing from
Dr. Shuren after this panel, but I think a lot of the problem
is that either the FDA does not have the resources or there are
problems at FDA in processing what is going on or there are
problems with the developers, the manufacturers who aren't
getting their studies done adequately. And I must say, when I
hear about weakening the standards, it bothers me because we
hear all the time reports about horrific patient suffering from
dangerous medical devices. In the last year, the New York Times
reported on radiation machines that have killed and disfigured
patients, malfunctioning linear accelerators that left a woman
nearly comatose. We have heard from the father of a patient who
died due to an overdose of radiation therapy, and we have also
heard about problems with the Sprint Fidelis implantable heart
devices that caused at least 12 deaths. I don't think devices
are something that we shouldn't take seriously as we do drugs.
They both must meet a safety and efficacy standard. In the face
of these reports of problems, it is hard to agree with the
sentiment that we need to reduce FDA's authority to make sure
medical devices are safe and effective.
Dr. Curfman, you testified on this subject. Should we be
looking at strengthening or weakening FDA's standards and FDA
authority for medical device approval?
Mr. Curfman. Thank you. It is a balance. We all want
devices to move quickly to patients so that our patients are
helped by them but at the same time they need to be evaluated,
and the clinical trial, the randomized clinical trial is now
the gold standard for evaluating drugs and devices, and we are
very fortunate in our country to have some of the leading
clinical trial centers in the world in the United States. This
has become a very expert scientific discipline to run a good
clinical trial, to do it right, to do it rigorously, to get the
right answers. And we are very fortunate now that this science
of doing clinical trials has become very, very sophisticated.
We have in the United States among the very best clinical
trialists in the world and they understand the importance of
doing these trials efficiently and quickly, and we at the New
England Journal understand the importance of publishing the
results of these trials quickly and efficiently.
Mr. Waxman. We had problems with drugs, and the concern
about the delay of approval of drugs, so a number of years ago
when I was chairman of this subcommittee, we put into law that
there would be a user fee that the manufacturers of the
pharmaceuticals would pay so that FDA could hire the personnel.
I don't like that idea. I think this is a government function
and we ought to be willing to pay for essential government
functions, and the FDA is one of those essential government
functions. But there was no way we were going to get more
appropriations.
Now, in the medical device area, we do not have a user fee.
We are relying on the money that the government appropriates
for FDA. I would be interested if anybody on this panel thinks
it is appropriate, given your concerns, that we reduce FDA's
money. I think the Republicans are proposing to reduce FDA by
$250 million, which would make them less able to approve drugs
and devices and to do the other things that they need to do
like food safety. Does anybody think it is a good idea to
reduce the funding for FDA?
Ms. Conger. Yes, I do, because I don't think that the FDA,
the organization as itself is functioning as efficiently as it
could be because----
Mr. Burgess. Well, you think they should be----
Ms. Conger [continuing]. They drag----
Mr. Burgess. I only have a limited time. So you think they
should be because FDA is not doing a good job. I want FDA to do
a good job, but FDA has to have the resources. There is a user
fee and there is a fight----
Ms. Conger. And the right people.
Mr. Burgess. They need the right people. They need to pay
the right people. You are not going to get good, competent
people to work for the government if you underpay them.
Ms. Conger. And don't----
Mr. Burgess. Excuse me. I am not in a conversation.
Ms. Conger. I am sorry.
Mr. Burgess. Perhaps another time. But the fact of the
matter is, proposals are to weaken the standards, spend less
money on the FDA, and all this has to be put in the perspective
of the Supreme Court decision that I think was misguided when
they said some medical devices are immune from lawsuits at the
State level.
Dr. Curfman, do you have any view on the Supreme Court
decision preempting lawsuits at the State level?
Mr. Curfman. Well, it is pretty irrational because there is
a different standard for drugs and devices. There is preemption
of State-level legal action for devices. There is no preemption
of State legal action for drugs. So it just doesn't make any
sense. There may be technical legal reasons why it came out
that way but we need to do something about that to make this a
more rational and logical system.
Mr. Waxman. Well, I just want to say in closing, I don't
think we are going to be moving in the right direction if we
reduce the money that goes to FDA, we don't get a user fee to
help them pay for the people reviewing the medical devices, and
then the answer isn't to say oh, just put them on the market
and we will see what happens. If people get hurt, they won't
use them anymore. If they are hurt because of negligence, they
can't sue. And then the FDA can't even conduct the oversight on
the safety and the efficacy of these products.
I know my time is expired. The chairman has been as
generous to me as he was to himself, and I thank him for it.
Mr. Burgess. And I thank the gentleman for recognizing
that. I will also point out that Dr. Sharfstein was here before
our committee last year and testified that they didn't need any
more money, they had plenty.
Let me yield to Mr. Terry from Nebraska for questions.
Mr. Terry. Thank you.
First, I mean, we on our side have been in discussions
about FDA and these delays. I haven't heard any of us talk
about weakening the standards, so I am sorry, I don't know
where that is coming from. We are frustrated that FDA has
become--the delays have become so difficult for the inventors
and manufacturers that they feel that they have to set up shop
in Europe in order to proceed. So we are trying to work through
that, Dr. Curfman. I don't know where you came up with the idea
or you and Henry Waxman that we are weakening.
But Ms. Conger, I felt badly the way that you were treated.
A question was thrown out that you weren't allowed to answer.
If you would like to use a little bit of my time to answer the
question?
Ms. Conger. The question about?
Mr. Terry. Mr. Waxman's about funding.
Ms. Conger. The funding, yes. I have been in business, and
I have seen organizations that stagnate and stagnate, and the
big kahunas on the top can't understand why their brilliant
ideas aren't filtering down into the little plants and the
roots and why aren't they going, and it is very simple. It is
that you do what you get rewarded for. You do the things you
don't get in trouble for. And while we may have some very, very
fresh ideas and even some of the things that I brought up, we
still have an old, ingrained guard that has been taught to keep
your head low and just keep doing it the old way, and the FDA
CDRH can no longer afford to do it the old way. They have their
competitors in other nations who are already bringing them tons
of data about products that are successful in millions of
patients----
Mr. Terry. Ms. Conger, that is a really good point there.
Ms. Conger. Yes.
Mr. Terry. And one that----
Ms. Conger. And then start them all over again. Excuse me.
Mr. Terry. Dr. Curfman, you are the defender here of the
status quo of the FDA.
Mr. Curfman. No, no.
Mr. Terry. So let me ask you this. Well, hold on. Her point
is one that is going through my mind, and let us use the low-
glucose suspend system where the conclusion of this mother, Ms.
Sagan, is that low-glucose suspend systems have been approved
for nearly 3 years and used safely all over, 40 countries
worldwide, but they are not available here. It seems to me that
our FDA refuses to acknowledge results and data from other
countries on the same device. Is that an appropriate standard?
Is that appropriate?
Mr. Curfman. Well, Mr. Terry, let me just comment about my
own interaction and experience with the FDA. I know many
people----
Mr. Terry. Would you answer my question?
Mr. Curfman. Yes, I am answering it. I know many people who
have served on advisory committees to the FDA and they are
highly expert. They are the best experts in the world. They are
providing the very best advice that the FDA can get, the best
advice anywhere in the world, and in the end, decisions about
what devices are going to put in the market have to be based on
evidence, not on feelings, not on impressions.
Mr. Terry. So are you saying that the--feelings and not
real data?
Mr. Curfman. Data from anywhere needs to be judged on its
merits, and that is what advisory committees do, and that is
why the FDA brings in the very best people from the medical
community, the scientific community----
Mr. Terry. And start all over.
Mr. Curfman [continuing]. And make these judgments, and to
evaluate the clinical trial data----
Mr. Terry. With my 48 seconds, let me ask you----
Mr. Curfman [continuing]. And to see if it really
supports----
Mr. Terry. Well, I appreciate you trying to run out the
clock here, but you were very critical of the European system
of approval. Can you detail their inadequacies?
Mr. Curfman. Sure. I have several concerns about it. First
of all, as you know, Mr. Terry, the European system is based on
76 private bodies, 76 in Europe, six in the UK, that make the
decisions about which products go on the market. So it is very
diverse. It is very spread. It is not a unified process. And
there is a lot of inconsistency among these 82 private bodies
that make these decisions. So that is one concern that I have:
inconsistency of standards across all of these regulatory
bodies.
Secondly, there is very little or almost no transparency to
the approval process in Europe. The FDA has a beautiful Web
site. All of the information about new devices and drugs is
available there. Anybody can find it. It is available to the
public. This is not true in Europe, and if you try to get
information in Europe, they tell you that is proprietary and
you can't get it.
Third, and I think of most concern, in Europe, for class
III devices, these are the most complex medical devices, it is
not necessary to show that that device is going to improve a
person's health before it goes on the market. That is of great
concern to me. We are living in an era now where outcome-based
medicine is what it is all about. This is core to medicine and
health today, to show that something improves a person's
health, and that isn't a requirement for putting a device on
the market in Europe. I think that is of great concern.
Mr. Burgess. The gentleman's time is expired, and I see
several people have their hands up, but we do need to go to the
chairman emeritus of the full committee, Mr. Dingell, for
questions.
Mr. Dingell. Thank you very much, Mr. Chairman. My
questions are going to require yes or no answers, and I am
sorry about that but there is a very limited amount of time and
a lot of questions to be asked.
These questions will go to Dr. Curfman. Your testimony
references two examples of innovative devices that were
approved without a clinical trial. As you know, new drug
applications require clinical trials for approval. Do you
believe that the two examples referenced in your testimony were
inappropriate for the 510(k) process? Yes or no.
Mr. Curfman. Yes.
Mr. Dingell. Now, Doctor, there have been reports of some
class III devices being reclassified as class II devices,
allowing them to gain approval through the 510(k) process
without need for clinical trials. In your work at New England
Journal of Medicine, have you found this to be a common
industry practice? Yes or no.
Mr. Curfman. Yes.
Mr. Dingell. Doctor, as you know, class III devices are
devices by their nature that should require a stricter review
by FDA. These devices are often necessary to sustain the life
of a patient and are in some instances implanted into the
patient's body. Is it true that a device that goes through
premarket approval process can be approved based on a single
clinical study? Yes or no.
Mr. Curfman. Generally, no.
Mr. Dingell. Should they be approved on the basis of a
single clinical trial?
Mr. Curfman. No.
Mr. Dingell. Do you believe that the clinical trial
standards laid out by FDA in the premarket approval process are
rigorous enough to prove safety and effectiveness of class III
devices? Yes or no.
Mr. Curfman. Most often, yes.
Mr. Dingell. Do you believe that a single study is
sufficient to approve a class III device? Yes or no.
Mr. Curfman. No.
Mr. Dingell. As you know, device manufacturers are required
to conduct postmarket surveillance. Do you believe that the
current postmarket surveillance requirements are adequate? Yes
or no.
Mr. Curfman. No, but they are getting better.
Mr. Dingell. So you think that is something we ought to
have a look at?
Mr. Curfman. Indeed.
Mr. Dingell. Now, Doctor, do you believe that the device
manufacturers have met their responsibility to conduct rigorous
postmarket surveillance to ensure the safety of their devices?
Yes or no.
Mr. Curfman. No, that is a big problem.
Mr. Dingell. Your testimony references the EU medical
device approval process and the timelines to approval are only
modestly shorter in the EU. How much shorter is the timelines
for approval? Can you give us some kind of a horseback guess on
that?
Mr. Curfman. Depending on what you are measuring, it can be
a few months to a year. In the lifespan of a drug or a device,
that is a small fraction of the total.
Mr. Dingell. Now, as you know, the standards for approval
in the United States and EU are different. Do you believe that
the EU approval process adequately takes into consideration the
success of a device in treating a patient? Yes or no.
Mr. Curfman. No.
Mr. Dingell. Do you believe that the approval process in
the EU is transparent to the public when approving devices for
use? Yes or no.
Mr. Curfman. No.
Mr. Dingell. Should be more transparent, should it not?
Mr. Curfman. Much more transparent, yes.
Mr. Dingell. Thank you very much for this. This goes to Dr.
Fischell and Dr. Ianchulev. I would like to end my questions
with you regarding your experience with FDA regarding the
medical device approval process. Please again answer yes or no.
Are you working with the FDA review staff and the approvals of
your device? Did you find that the FDA review staff was
responsive to questions or concerns? Yes or no.
Mr. Fischell. No.
Mr. Dingell. Now, were the requirements for the approval of
your device made clear to you by the FDA review staff in the
beginning? Yes or no.
Mr. Ianchulev. No.
Mr. Fischell. No.
Mr. Dingell. Have you found the review process to be
consistent? Yes or no.
Mr. Ianchulev. No.
Mr. Fischell. No.
Mr. Dingell. Do you believe that the review staff at the
FDA are adequately trained to review the devices based on the
most up-to-date science? Yes or no.
Mr. Ianchulev. No.
Mr. Fischell. No.
Mr. Dingell. Now, I would just like to comment in the 26
seconds left to me, Mr. Chairman.
Mr. Stearns. Will the gentleman yield just for question?
You might want to give them a chance to--it looked like some of
them didn't have a chance to answer.
Mr. Dingell. My time is running.
Mr. Stearns. OK. No problem.
Mr. Dingell. My time is running, Mr. Chairman.
Way back, we had a nasty experience in this country. It
related to a substance which caused problems with regard to
babies given to mothers for morning sickness. It was approved
in Europe but it was not approved over here. It resulted in a
whole big change in our food and drug laws, and it was a matter
of very special concern. The precise name of the
pharmaceutical, I don't remember.
Mr. Fischell. Thalidomide.
Mr. Dingell. Thalidomide. Thank you very much. It caused a
huge stir and a tremendous amount of difficulty because of the
way the Europeans went into these matters as opposed to the way
that we went into them, and I am very loathe to see us
weakening our laws to simply carry forward the goals of the
Europeans, who occasionally make mistakes too.
Mr. Chairman, you are most gracious. Thank you.
Mr. Stearns. The gentleman yields back.
I would like to put into the record--the gentlelady, the
ranking member, has asked the supplemental memorandum July 20th
be put into the record. By unanimous consent, so ordered.
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Mr. Stearns. Mr. Terry wanted to put this New York Times
article in, the ``Medical Treatment, Out of Reach.'' So
ordered.
Then I have a 510(k) survey results researchers from
Northwestern University into the record. The Northwestern
researchers surveyed more than 350 medical device development
specialists on their experience with FDA and medical device
review process compared with that of the European Union, and
they show that two-thirds of the small medical device and
diagnostic companies are obtaining for new products in Europe
first and the survey shows that 76 percent of the respondents
said preparation requirements for 510(k) submission were
uncertain or unclear, and I think this is a good study to be
part of the record, and FDA needs to provide predictability and
certainty for companies or they will continue to go to Europe.
With that unanimous consent, so ordered.
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Ms. DeGette. Mr. Chairman.
Mr. Stearns. Yes?
Ms. DeGette. Also, just to clarify, attached to our memo
are two letters, one from the--five, sorry--four--some number--
five letters supplementing that.
Mr. Stearns. All right. By unanimous consent, that is so
ordered.
And now we will go to the gentlelady, Sue Myrick is
recognized for 5 minutes.
Mrs. Myrick. Thank you, Mr. Chairman.
Dr. Fischell, I would like to just cover a couple things
with you. Thank you, all of you for being here today and your
testimony, by the way. You have been doing this for a long
time, not just innovating but helping patients, et cetera, and
a comment was made a little while ago about European
inconsistencies and standards, I believe by Dr. Curfman. You
have been talking, all of you, kind of about the fact that, you
know, the Europeans are doing things quicker and we are taking
a lot longer. Do you feel from what you have had experience
with over the years and looking at the European standards that
there is a lot of inconsistencies and that they are not doing a
good job?
Mr. Fischell. No, I don't think that is the case, and I
would like to once give the example of the migraine device.
When we showed to the European notified body that we had done a
clinical trial that proved it was safe and effective in the
treatment of migraine, when we showed that there was already an
FDA-approve device used for many years that had 20 percent
stronger pulses and 30,000 times more and that was approved, it
seems to me that the Europeans were logical in saying it is now
approved for use in Europe. That seems logical to me.
Mrs. Myrick. Well, and the other thing was, and Dr.
Curfman, you said sometimes they are just a few months to a
year behind. They have been waiting since 2006 for approval of
that particular machine, which is a little longer than a few
months to a year. But anyway, I wanted to ask you another
question because you mentioned when you talked about the
innovation and people going overseas and whatnot, if you were
starting out today, would you still be able to find the same
availability of funding for what you are doing? Because you
mentioned something about funding in your remarks.
Mr. Fischell. We have--a month ago a venture capitalist
said they would not give us the last money we need to get this
product approved, the migraine product in the United States,
because the FDA approval process is so risky that they would
not risk the capital. We have worked with VCs over many years
and we were well funded to do our stents, to do our
defibrillator and pacer. They are no longer funding us. It is a
real struggle now to get the funds to do the innovation, to
make the jobs in America because the FDA has scared the venture
capitalists.
Mrs. Myrick. Well, and that brings me to another point. We
have got over 40 device manufacturers in Charlotte alone, where
I am from. North Carolina has a tremendous number because of
all the medical there, you know, device manufacturers which is
creating jobs. They pay well and, you know, the delays in
approval are keeping these jobs from being created here in
America and so, you know, to me, this has a tremendous impact
on what is happening here, what the FDA does relative to us
being able to create those jobs that are obviously being
created in other countries instead of here.
Mr. Fischell. You know, a migraine company only has 12
people employed and yet we are now hiring people in Europe to
get it out into the population there. That doesn't make an
American happy.
Mrs. Myrick. No, it doesn't make any of us, very frankly.
Ms. Conger, I would like to ask you because of, you know,
we know that the job of FDA is to make things safe. None of us
are trying to say you shouldn't have safe devices and they
should be effective, but they are supposed to also foster
innovation, and just from our perspective, what do you think
the balance should be between those two in how the FDA is
running.
Ms. Conger. Based on my research about other approval
methods and their successes and failures, and I compare it to
our current overly bureaucratic, overly politically worried
system. We can have all three. We can have safety, reasonable
safety, efficacy and innovation if we were using parts of
models of other countries that are doing it so well. We have
the opportunity to take the learnings of others, add it to the
gems we know we do well, and come out with a better system. As
it is set up now, it is not going to work.
Mrs. Myrick. Can I quickly ask, Dr. Ianchulev, you worked
in both systems relative to the European standards. I would
just like your comment.
Mr. Ianchulev. Yes. Actually, I am licensed in Europe as
well as a physician and to me that has been--when I came to
this country almost 20 years ago, I came here to innovate and
practice cutting-edge medicine, and I have seen to my surprise
that a lot of my European colleagues now have more advanced
experience than what I can get here and deliver to my patients.
And I have experienced the review process on the regulatory
side in Europe and I would say that I haven't noticed it to be
irrational nor have I heard from my colleagues or patients in
Europe to feel that the environment is unsafe. At the same
time, I should say that we don't have to rubber stamp
something. It is a matter of looking at this is not a bearing
point and another way to benchmark ourselves to find something
that works for us and for our patients.
Mrs. Myrick. I appreciate it. Thank you, Mr. Chairman.
Mr. Stearns. I think just to confirm what you indicated to
the gentlelady, over in Europe they have more advanced
experience, you said?
Mr. Ianchulev. In my field, for example, we have a lot of
medical devices that we use, mainly new types of intraocular
lenses, and to be more specific, there are other ones right
now, new minimally invasive treatments for eye diseases such as
glaucoma, and it is interesting that on the device side on the
European side, you can see access to those technologies and
experience in the hands of physicians, which is probably the
only true way to appreciate not just read an article in a
journal but really to have experience with the device. That is
what physicians need to understand it.
I think on the drug side, it is opposite. I have noticed a
lot more experience happens first here and then travels to
Europe, and that was my experience with Lucentis why we got it
approved here and followed one year later there. It is just my
personal experience is----
Mr. Stearns. OK. Thank you.
The gentleman from Texas is recognized for 5 minutes, Mr.
Green.
Mr. Green. Thank you, Mr. Chairman, and I would like
unanimous consent to have a statement placed into the record,
and I do have concerns because I know medical device companies
who produce in our countries but there are rules particularly
in Europe that they can't market a device there that is not
admitted into the home country so they end up having to move
their production facilities to another country. We may not want
to lower our standards to the European standards, because I am
going to ask Dr. Curfman some questions about that, but Dr.
Curfman, I understand actually in some cases FDA is much
quicker than in Europe on the reviews. Can you outline some of
the concerns with the medical device approval system in the
European Union?
Mr. Curfman. Well, I think again the most important thing
in a review process is to ensure that a new device or a new
drug is actually going to result in a better health outcome for
the patient.
Mr. Green. And Europe doesn't require that?
Mr. Curfman. Europe doesn't require that. We do. And I
think that that is really a fundamental difference in the two
processes.
Mr. Green. And the structural way that the FDA does our
approval but in Europe from what I understand, there are 74
for-profit entities that actually can be--you can almost cherry
pick who you want to take your device to. Is that correct?
Mr. Curfman. That is correct.
Mr. Green. And the European Union allows any of those 74 to
make that determination that the FDA does in our country?
Mr. Curfman. That is correct.
Mr. Dingell. If the gentleman would yield, those things are
called forum shopping over here.
Mr. Green. Oh, I understand. But that gives the companies--
and I am amazed that Europe doesn't have some more quality
control on what they do, but that is beside the point. Can you
continue about the difference between us, the United States
requirements under FDA and in Europe?
Mr. Curfman. Well, I think another point that we touched
upon briefly is the issue of transparency, and that is putting
information out to the public, getting it up on a Web site. The
FDA does a beautiful job of that. The FDA's Web site is highly
sophisticated, very deep in information. That doesn't exist in
Europe.
Mr. Green. In our country, if someone is wanting to use a
device, it is available, the information from the FDA because
it is public record.
Mr. Curfman. That is correct.
Mr. Green. But those 74 entities, I understood from earlier
testimony that that is proprietary information.
Mr. Curfman. That is proprietary information, and there is
no information about who the decisions are being made, what the
process was, who the people were who were involved in making
those regulatory decisions. In the FDA, that is all very
transparent. You know exactly who did what.
Mr. Green. Well, I understood a statement earlier, and you
wouldn't believe it from our panel today that the FDA is
actually faster then the European Union on devices. Do we have
a percentage or has anyone looked at that? And if somebody has
some other--I want to hear Dr. Curfman first because he is in
the business right now. Is that information that is readily
available?
Mr. Curfman. I would imagine that Dr. Shuren would have
that information probably more than I would.
Mr. Green. Well, Mr. Chairman, hopefully we can get that.
Again, it sounds like we are comparing apples and oranges with
results.
What are the problems with abandoning the effectiveness
criteria for medical device approval in moving to the European
standard?
Mr. Curfman. Well, you know, in medicine and health care
today in the United States, we talk about evidence-based
medicine. This is the core of our process in finding new
therapies. New therapies need to be supported by real evidence,
by clinical trials, by scientific data, not just casual
impressions that they work in that patient so they will work in
every patient but real solid clinical trials, and doing
clinical trial is very difficult but we have gotten in the
United States very good at it. It has become a very refined
science so that we can get very good and precise answers to
these questions about whether new drugs and devices really work
by helping people's health. We can do that today.
Mr. Green. I only have about 26 seconds. In Europe, if I
was a medical device company and hired one of those entities,
those for-profit entities to do it, that patient wouldn't be
able to know anything about how the clinical went. Is that
proprietary information in Europe?
Mr. Curfman. Yes, not only the patient but physicians.
Nobody would really know that. There is no way to get it. And
if you try to get it, they simply say it is proprietary
information, we won't release it. It is astonishing that that
would be allowed to happen because it is so strikingly
different here.
Mr. Green. Thank you, Mr. Chairman.
Ms. Sagan. Mr. Chairman, I feel compelled to ask to be able
to make a statement. I am sorry. In terms of the low-glucose
suspend insulin pump, there is no safety issue. It is not safe
to not allow the low-glucose suspend system to come into being,
into practice in the United States. If you understand type 1
diabetes, it is too dangerous to allow insulin to be pumped
into a body that is experiencing low blood glucose, more
dangerous than running a 90-minute period of running high
glucoses. My daughter's glucose level has been at 500 many,
many, many times, and the long-term complications of high
sugars are far diminished by the short-term complications.
Mr. Green. I thank the gentlelady.
We have a request that we recess our committee. We are
doing some votes in another subcommittee, and the chairman has
asked that I recess the committee temporarily so that all
members could go to this other committee, so with your
indulgence and forbearance, I would appreciate your waiting,
and I tell all members that we are going to recess the
committee and we will try to get back shortly.
[Recess.]
Mr. Stearns. The subcommittee will reconvene, and I thank
all of you. If the witnesses would please come to the table
again, we will start the questions here, and we were able to
receive a unanimous consent agreement that the votes at this
other committee will be rolled until after our votes in the
House, which will probably occur between 1:15 and 1:30. So I
don't want to hold up the witnesses here anymore.
Are Mr. Mandel and Dr. Ianchulev close by? I just want to
make sure--they can't be far. I think under the time
constraints we have, I think we will start with the gentleman
from Georgia, Mr. Gingrey, for questions and we will just keep
moving forward here. So the gentleman is recognized for 5
minutes.
Mr. Gingrey. Mr. Chairman, thank you. Thank you very much.
I am going to confine my questions and remarks to Dr. Curfman.
Dr. Curfman, of course, as executive director of the New
England Journal of Medicine and a cardiologist, I too am an
M.D., as you know, and certainly it is an honor have you come
before the committee to testify, and we thank you for being
here today, as we do the other witnesses. I think you have been
very patient and you have been very good with us.
Dr. Curfman, in your testimony, you state your support for,
and I quote ``high-priority innovation in medical devices'' but
conclude that the glamour of innovation does not always work
for patients if we cut corners in quality control. Is that a
fair assessment?
Mr. Curfman. Yes, that is exactly right.
Mr. Gingrey. As examples of cutting corners in quality
control, your testimony focuses on two products that you say
ran through the 510(k) fast-track process versus the more
rigorous premarket approval process. Had the Sprint Fidelis
defibrillator gone through the more rigorous PMA, that
premarket approval, versus the 510(k), do you believe that some
patient injuries might have been avoided?
Mr. Curfman. I think that probably the way to have done
that would be to phase it in rather than doing a clinical
trial, that instead of launching this into many thousands of
patients in a short period of time, to set some benchmarks for
the lead in a limited number of patients and try to see if any
problems were emerging there. The problem with this lead was
that it was made quite a bit thinner than previous leads, and
it was----
Mr. Gingrey. And in your testimony, you said that that
approval process of Medtronic's Sprint Fidelis lead was fast-
tracked, it was through that 510(k) process.
Mr. Curfman. Yes. There was no clinical testing. So what I
would propose is that there be some clinical testing----
Mr. Gingrey. Right. Well, I understand that.
Mr. Curfman [continuing]. In a limited number of patients.
Mr. Gingrey. I want to ask you this, because I am holding
in my hand a PMA record, premarket approval record, number
P920015 for the Medtronic's Sprint Fidelis lead dated 2007,
which in fact means that the Sprint Fidelis product did go
through the more rigorous PMA supplement process and not the
510(k) as your testimony suggests. Are you aware that your
testimony on this is factually wrong?
Mr. Curfman. I don't think it is wrong.
Mr. Gingrey. Well, here it is.
Mr. Curfman. Well, I would have to----
Mr. Gingrey. Let me just follow up on that, and maybe you
can check your notes or maybe talk with your secretary or
whomever gave you this information. Your testimony also cites
the federal preemption for medical devices that prevented U.S.
patients from suing Medtronic. Doctor, the federal preemption
for medical devices only applies to class III products that go
through the PMA process, not those that go through 510(k). The
fact that this reality did not raise a red flag for you when
drafting and reviewing your testimony here today is troubling,
to say the least.
The second example you cite in your testimony as proof of
510(k) failure is this metal-on-metal hip. Dr. Curfman, the
Safe Medical Devices Act of 1990 directed the FDA, and I will
say that again, this act directed the FDA to review certain
class III devices and to ascertain whether they should be
reclassified and go through this premarket approval process,
so-called PMA, as I held up on the other one with Medtronic.
One of these devices is the metal-on-metal hip yet 20 years
later the FDA has yet to conduct a review. So it appears that
the failure of this product is not due to 510(k) process but to
regulatory inaction by our own FDA. So Dr. Curfman, do you
believe that the FDA should follow the direction of Congress
and implement the Safe Medical Devices Act of 1990 in order to
better protect patient safety?
Mr. Curfman. Well, I think that it is important for some of
these previously approved devices to be looked at again, and--
--
Mr. Gingrey. Indeed, that is what the 1990----
Mr. Curfman [continuing]. I would support that.
Mr. Gingrey [continuing]. Act called for.
Mr. Curfman. That is correct. Yes, exactly. So I think that
it should be done selectively but I think that some of these
previously approved devices do need to have another look.
Mr. Gingrey. Well, absolutely, and I agree with you
completely, Dr. Curfman, and I think we could have avoided some
huge problems if that had been done. Both instances you cite to
support the failure of this 510(k), the fast-track process,
appear to be either inaccurate or factually incorrect, and with
all due respect, these inaccuracies call into question, I hate
to say it, but, you know, as a distinguished doctor and
executive editor of one of our most distinguished medical
journals, the New England Journal of Medicine, these little
simple inaccuracies call into question what you describe as
your careful analysis of these two studies you reference in
your testimony.
Mr. Curfman. No, I disagree, Dr. Gingrey. I think that
everything that I have said is accurate. I point out to you
that the Sprint Fidelis lead was removed from the market in
2007. This document that you have given me is dated 2007. So
something doesn't quite add up here. It was pulled from the
market in 2007 by Medtronic. So I am not sure what this
document----
Mr. Gingrey. Well, I would be happy--I think my time is
expired.
Mr. Stearns. The time has expired.
Mr. Gingrey. Doctor, I would be happy to have you follow up
with written testimony to the committee.
Mr. Curfman. I would be happy to do that.
Mr. Stearns. I think the gentleman from Georgia----
Mr. Gingrey. If there are some corrections that you would
like to put into the record, we would be glad to put that into
the record.
Mr. Curfman. I would be happy to do that.
Mr. Stearns. Dr. Gingrey, if you feel comfortable, you
could also ask him questions and we can ask him to reply for
our record too.
With that, I recognize Ms. Christensen----
Mr. Gingrey. Thank you, Mr. Chairman. I yield back.
Mr. Stearns [continuing]. For 5 minutes.
Mr. Christensen. Thank you, Mr. Chairman, and I want to
thank the panelists, especially those who are patients or
representing patients. I think everyone up here felt your pain.
And just before I ask my question, I just wanted to say that I
understand that despite all of the comparisons between Europe
and the United States, I still understand that the U.S.-based
companies dominate the industry globally, medical device
industry, and it is also interesting to note that the medical
device industry is one of the few sectors with a positive trade
balance today in our struggling economy.
Dr. Curfman, it seems like you are getting all of the
questions today. I would like to ask you about the effect of
regulation on innovation within the medical device technology
field. In your written testimony, you stated that innovation is
essential--I am quoting you here--``innovation is essential to
the future or our Nation's health but innovative medical
products cannot succeed unless they are both effective and
safe.'' Can you explain how innovation in the medical field is
fostered by sensible quality safeguards?
Mr. Curfman. Yes. Thank you, Dr. Christensen. I think that
real innovation, real innovation needs to involve products in
which the efficacy has been clearly demonstrated and the safety
has been clearly demonstrated. Otherwise it is not real
innovation. We have talked about creating jobs in the medical
device industry, and I think we all feel that that is a very
important goal, but we don't want jobs to be created to create
defective medical devices that don't work, that cost a lot of
money, that pull money out of our health care system that could
be better used in other ways on things that do work or on
devices that are not safe. So this is why I have tried to make
a case that an important part of innovation is to really
establish that the product works and that it is safe and that
if you don't do that, it is not real innovation.
Mr. Christensen. FDA must--and we have to support them in
protecting the health and safety of millions of patients in our
country, and the agency can only accomplish this when novel
drugs and new devices are rigorously evaluated for safety and
efficacy. In your opinion, do manufacturers always take
appropriate premarket steps necessary to protect patient
safety?
Mr. Curfman. In my experience, they do not always do that,
and that is why oversight is necessary. That is why regulation
is necessary. That is why it is important for third parties to
be taking a look at these products and doing some oversight and
ensuring that efficacy and safety are really established.
Mr. Christensen. So that must contribute to some of the
delays as well?
Mr. Curfman. It does. There is a process involved. It does
take time. I am sure that these delays can be reduced. I think
that that should be a goal of the FDA. But that doesn't mean
that the process should be eliminated.
Mr. Christensen. Well, many have criticized, and we have
heard it today, FDA for stifling innovation with their rules
and regulations concerning medical devices. In your opinion,
has FDA made the approval process for medical devices too
onerous for medical device manufacturers?
Mr. Curfman. My experience with the FDA is that they are
keenly interested in innovation. They are keenly interested in
improving the lives of patients. They want to get products to
market. That is my sense. At the same time, they know that a
process establishing efficacy and safety is a critical part of
that process.
Mr. Christensen. Well, are there ways that the FDA could
strengthen some of the aspects of their approval process?
Mr. Curfman. Well, as Congressman Waxman said, in order to
do that, they need resources. So I think that the first thing
is that we can't cut their budget and expect them to improve
their processes. There is just a disconnect there. So I think
we need to look at the budgeting process and be sure that they
have the resources that they need to do the job.
Mr. Christensen. Thank you. And I think more than ever now,
we need to make sure we are making smart choices on the budget
and cuts to FDA as we have done already make no sense. They
really hurt patients. They hurt companies that want to bring
innovative drugs and medical devices to the market. Thank you.
I am out of time.
Mr. Stearns. I thank the gentlelady.
I think by mutual agreement, we are going to the gentleman
from California, Mr. Bilbray. You are recognized for 5 minutes.
Mr. Bilbray. Thank you, and I appreciate the doctor's
questions. I think the delegate from the Virgin Islands has a
background here. You know, we have got some indicator species
here as we say in the environmental community that are not
being observed, and that is, the venture capital that goes into
this innovative technology. It is not--you know, by the time it
gets to the FDA, it is at the end of the line, and I just want
to say right now, July 11, everybody is put on notice, 50
percent of the venture capital investment in medical devices
and research has dropped off in my region. Now, that is the
krill of medical breakthroughs, and, you know, when the krill
dies, in a few years you are going to say well, what happened,
why isn't there any new information. Because the big guys use
that krill to feed on. So there is a concern here that we may
be contributing to the extinction of a species that we take for
granted but it essential in the food chain of medical
breakthroughs.
Dr. Curfman, I have got a question for you. Do you believe
the defibrillators that we have got out in the public are as
effective in the hands of a layman as they would be in a
trained physician?
Mr. Curfman. You are talking now about defibrillators----
Mr. Bilbray. The defibrillators----
Mr. Curfman. The manual defibrillators?
Mr. Bilbray. The manual defibrillators.
Mr. Curfman. Well, the automatic external defibrillators
can be operated by a layperson with only a small amount of
training, and they are designed to do that and they can
certainly be lifesaving.
Mr. Bilbray. But they can be lifesaving. We agree with
that.
Mr. Curfman. Yes.
Mr. Bilbray. But do you think that they are just as
effective in a layman's hands as it would be in a trained
cardiologist's hands?
Mr. Curfman. Well, you need some training to use these.
They are not totally intuitive. If you have never, never used
one, you are going to have to figure it out. They are certainly
a lot easier than older ones.
Mr. Bilbray. Do you have any idea how long it took us to
finally approve this and get it out in the field?
Mr. Curfman. Well, it took some years, yes.
Mr. Bilbray. OK. Do we have any idea of how many people
died of cardiac arrest in public during that period? We don't
have any idea at all. But we can only imagine.
You know, I have just got to say, we talk about the morning
sickness medicine of the 1950s that caused birth defects, and
that is what you remember as the chairman emeritus said. They
don't think about Benedictine in the 1980s that was perfectly
safe but driven off the market, and a lot of it was because you
remember the stuff when it goes bad but you don't think about
all the savings, and I think we all agree. Aspirin, classic
example, hundreds of people die every year, and it has probably
done more to help with health of probably any device
My question is this. When we talk about the device that Mr.
Mandel talked about and with 3 percent increase annually in
child melanoma annually since the 1970s, we have got a device
that physicians could use that may help in that application but
because it cannot be proven to as effective as a dermatologist,
don't you think we have got to start talking about reality,
that early detection is the most essential part of surviving
melanoma. Wouldn't you agree?
Mr. Curfman. Absolutely.
Mr. Bilbray. And why would we say that we do not want to
give a device to general practitioners that see the
overwhelming majority of children--why would we as an agency
say this should only be used at the back end of the process,
dermatologist, after the general practitioner has sent them
over?
Mr. Curfman. Like any device, the efficacy needs to be
established. This is a device where there are probably not
going to be any safety issues but there are efficacy issues. It
is a device that costs money. It has to be shown to be
accurate.
Mr. Bilbray. Costs money.
Mr. Curfman. It has to be accurate. It has to work and it
has to be shown to work.
Mr. Bilbray. But----
Mr. Curfman. And the evidence has to be there, and if you
don't have the evidence, you can't just approve the device.
Mr. Bilbray. But if you have the evidence to apply----
Mr. Curfman. You need the evidence. You need the evidence
in a real clinical study.
Mr. Bilbray. Excuse me. But if the technology works for a
dermatologist, OK----
Mr. Curfman. Who says? That is the point of doing clinical
studies, to get the evidence.
Mr. Bilbray. OK. Let us back up then. The same clinical
trials that say you apply, why would you shift it? If it works
good for a dermatologist and it works, why would a bureaucracy,
why would a government agency say we don't want this to be
applied at the general practitioners, we are going to make a
judgment call that we want it to be applied for dermatologists.
Now, don't you agree as the manual defibrillators but
especially with melanoma, that early detection, if there is an
opportunity, early detection with general practitioners, that
is an essential part of treating that disease and addressing
that disease and that is prevention. The earlier the better,
right?
Mr. Curfman. Absolutely.
Mr. Bilbray. OK.
Mr. Curfman. So what you need to do is show that the device
detects it earlier and improves patient outcomes.
Mr. Bilbray. OK. If you wanted to prove that, then why
would you not allow a review board to look at this and review
it? Why would you say we are not going to allow a review board
to take a look at this and review it?
Mr. Curfman. I think that you have to have the proper data
in hand for the review board to look at, and I am not
completely familiar with this device so I can't really say how
much data they had, but I am assuming that they don't have
enough data for the review board to review it.
Mr. Bilbray. And let me just mention, Mr. Chairman, I think
the one we asked about that has been brought up here, do you
agree that we had a great success in the 1990s with AIDS by
allowing patients to sit on the review boards? Do you think
that diabetics and cancer patients should have the same
opportunity in this century as we gave in the last century to
AIDS patients?
Mr. Curfman. Yes.
Mr. Bilbray. Thank you, Mr. Chairman.
Mr. Stearns. I thank the gentleman. His time is expired.
Panel, we are going to ask one more 5 minutes and then you
will be excused, so we will finish.
Mr. Griffith is recognized for 5 minutes.
Mr. Griffith. Thank you, Mr. Chairman. I would like to
yield 3 minutes of my 5 minutes to Mr. Gingrey and then 2
minutes to Mr. Lance.
Mr. Stearns. So ordered.
Mr. Gingrey. Well, I thank the gentleman for yielding time
to me. I wanted to, during the last discussion when my 5
minutes expired and I was talking with Dr. Curfman, I had a
question for Mr. Fischell. On that note, I want to return to
you fairly quickly. Given my concerns, Mr. Fischell, with the
testimony of Dr. Curfman, I was wondering if you could share
your thoughts on the veracity of those two studies that were
outlined in Dr. Curfman's testimony. He didn't think too highly
of them. Could you give us your opinion on those studies?
Mr. Fischell. I am not an expert on that, and I think that
they were PMA supplements, which are treated differently from
PMAs, and I think that may account for some of the difference
here. But I am by no means an expert on that subject.
Mr. Gingrey. Well, I appreciate your honesty on that. The
PMA supplement is reviewed in those articles using the same
standard as the original postmarket analysis, PMA. So I want
that to be in the record and I want that statement to be in the
record.
In the last minute or so that I have before I think my
friend wants to yield to another colleague on this side of the
aisle, look, I think we are all here for the right reasons.
There is certainly a difference of opinion on one end of the
table from most of the other witnesses in regard to the FDA and
are they doing their job in a most efficient, timely manner
that is safe for patients. Obviously, as Dr. Curfman pointed
out, safety is hugely important, but to make it so difficult
losing venture capitalists, we are losing research and
development, we are losing new products to the European Union,
and then they come back over here and finally get to our market
but all the jobs----
Mr. Stearns. The gentleman's time has expired.
Mr. Gingrey [continuing]. Are gone. That is what this is
all about, and I thank the gentleman for yielding to me and I
yield back.
Mr. Stearns. The gentleman, Mr. Lance, is recognized for 2
minutes.
Mr. Lance. Thank you very much. I will take 1 minute, and I
appreciate the courtesies of my colleague, Mr. Griffith.
Dr. Fischell, I represent a district that is really the
medicine chest of the country in north central New Jersey, more
pharmaceutical and medical device employees than any other
district in the United States. In your testimony, you state
that beyond the adverse impact FDA is having on patient care,
it is weakening the U.S. leadership position in medical
technology innovation and as a result our economy. Would you
comment briefly on that statement with which I agree and is so
terribly important to the district I serve?
Mr. Fischell. Well, it has been very clear to me personally
by the fact that from 20 to about 5 years ago, venture
capitalists would come to me and say Dr. Fischell, I would like
to support your latest innovation, tell me what it is. Now I
have recently gone to venture capitalists and said we have this
great new cure for migraine and I need another $2 million to
finish it. They said because of the FDA, we can't give it to
you, it is too risky. That is the difference.
Mr. Lance. Well, thank you very much, and I appreciate
having the opportunity to speak with you on that, and I yield
back the balance of my time.
Ms. DeGette. I am wondering if Mr. Griffith would just
yield to me for one brief moment?
Mr. Griffith. One brief moment, I yield to the gentlelady.
Ms. DeGette. Thank you very much.
I just want to point out, there was a Bloomberg News
article today that said venture capital funding for medical
device and equipment makers gained 20 percent to $840 million
in 90 deals over the last 3 months, so I think the record needs
to reflect that there is still ample venture capital for
medical devices as well as for all of biotechnology, and
anything this committee can do to encourage that----
Mr. Gingrey. Mr. Griffith, would you yield to me for
unanimous consent?
Mr. Stearns. No, I think we are just going to wrap up here.
Mr. Gingrey. Mr. Chairman, I do have a UC request.
Mr. Stearns. OK. Go ahead.
Mr. Gingrey. I would like to for unanimous consent request
to submit for the record these materials that I am holding be
inserted into the record, and it is important because these
materials show that the Medtronic device that Dr. Curfman was
talking about----
Mr. Stearns. OK. I think what we will do is----
Mr. Gingrey [continuing]. Was approved through PMA and not
the 510(k) process. That is all this does.
Mr. Stearns. The minority needs to see it, and we also have
here a quote from the New York Times----
Ms. DeGette. Reserve the right to object.
Mr. Stearns [continuing]. And the LexisNexis also, so we
have three items.
Let me close, and we are going to recess the committee and
thank the panel for their very compelling testimony and we
appreciate your forbearance, and so we will take up the second
panel after the set of votes, and so the subcommittee is
temporarily in recess.
[Recess.]
Mr. Stearns. The subcommittee will come to order, and now
we will proceed to our second panel, and Dr. Shuren, you have
been very patient with us and we appreciate that, and we are
glad to have Mr. Waxman with us as we proceed to the second
panel.
With that, I will swear you in. Let me start by saying you
are aware that the committee is holding an investigative
hearing, and when doing so has had the practice of taking
testimony under oath. Do you have any objection to testifying
under oath?
Mr. Shuren. I do not.
Mr. Stearns. The chair then advises you that under the
rules of the House and the rules of the committee, you are
entitled to be advised by counsel. Do you desire to be advised
by counsel during your testimony today?
Mr. Shuren. I do not.
Mr. Stearns. In that case, if you would please rise and
raise your right hand?
[Witness sworn.]
Mr. Stearns. You are now under oath and subject to the
penalties set forth in Title XVIII, section 1001 of the United
States Code. You may now give a 5-minute summary. Your written
testimony will be part of the record. Proceed. Thank you.

TESTIMONY OF JEFFREY E. SHUREN, DIRECTOR, CENTER FOR DEVICES
AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION

Mr. Shuren. Mr. Chairman and members of the subcommittee, I
am Dr. Jeff Shuren, Director, Center for Devices and
Radiological Health, or CDRH, at the Food and Drug
Administration. Thank you for the opportunity to testify today,
and I would like to thank the participants on the first panel,
who raised many important points that I agree with.
The mission of the FDA is to protect and promote the public
health, to protect the public health by assuring that the
devices that come on the market are safe and effective, and to
promote the public health by facilitating innovation. Striking
the right balance is challenging but also critical.
In September 2009, soon after I came to CDRH, we initiated
a review of our medical device premarket review programs in
response to concerns expressed by industry and others. We
conducted and honest and frank self-assessment of these
processes including the 510(k). In 2010, we released two
reports which concluded that we had not done as good a job
managing our review programs as we should, and proposed
potential solutions for improvement. The number one problem we
found was that there was insufficient predictability in our
premarket review programs which contributes to inconsistent
decisions and longer terms to market. We identified several
root causes. They including changing, unnecessary,
inappropriate and/or inconsistent data requirements imposed on
device sponsors, insufficient guidance for industry,
insufficient interactions between the agency and industry, very
high reviewer and manager turnover at CDRH, turnover that is
almost double that of FDA's drugs and biologic centers,
insufficient training for reviewers, insufficient oversight by
center managers, CDRH's rapidly growing workload due to the
increasing scientific and technological complexity of the
devices we reviewed and the number of submissions we received,
and poor quality submissions by industry.
We solicited public comment on these reports from
stakeholders and heard a wide range of perspectives. This past
January, we announced 25 specific actions that CDRH will take
in 2011 to improve the predictability, consistency and
transparency of our premarket review programs, and have since
announced additional actions. For example, we have made a
commitment to develop a range of updated and new guidances to
clarify CDRH requirements for timely and consistent product
review including device-specific guidance in several areas such
as mobile applications and artificial pancreas systems. We are
also working to revamp the guidance development process to make
it more efficient. We are enhancing the interactive review
process and streamlining the review program for low- to
moderate-risk novel devices called the de novo process. We are
streamlining our clinical trial program to assure that clinical
trials can start in a timely manner. We have already
established a new center science council to help ensure
consistency and predictability in our scientific decision-
making, and we are creating a network of experts to help us
resolve complex scientific issues and product assessment, which
we hope will ultimately result in more timely reviews of device
submissions. We are instituting a reviewer certification
program and a pilot experiential learning program to provide
review staff, especially our newer review staff, with necessary
training and real-world experiences.
These efforts signify our commitment to improving our
premarket review programs to ensure that patients have timely
access to safe and effective devices and the U.S. device
industry remains strong and innovative.
Mr. Chairman, I commend the subcommittee's efforts and I am
pleased to answer any questions the subcommittee may have.
[The prepared statement of Mr. Shuren follows:]

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Mr. Stearns. I thank you, Dr. Shuren.
Just so there is no lingering uncertainty with respect to
Medtronic Sprint Fidelis approval that was discussed on the
first panel, I think you were here to listen to that, was the
Medtronic device at issue approved as a 510(k) as Dr. Curfman
stated in his testimony?
Mr. Shuren. No.
Mr. Stearns. Well, then that and other factual inaccuracies
that also included in Dr. Redberg's letter to Ranking Member
Waxman, which is attached to the Democrats' supplemental memo,
throws into serious doubt Dr. Curfman's and Dr. Redberg's
conclusions. I ask the gentlelady, does the minority still wish
to include that supplemental memo in the record?
Ms. DeGette. Yes, it has already been included.
Mr. Stearns. OK. We just wanted to establish that.
Dr. Shuren, you have been at the FDA not just the 2 years
in this present position, how many years were you before that?
Mr. Shuren. I first started in 1998 but I also worked over
at the Medicare program, and I came back in 2003 and had been
there since then.
Mr. Stearns. So that is 8 years from 2003, and before that
how many years were you there?
Mr. Shuren. About----
Mr. Stearns. Two?
Mr. Shuren. Approximately two.
Mr. Stearns. So our records show you actually have been
there 10 years. Would that be a fair statement?
Mr. Shuren. That would be a fair statement.
Mr. Stearns. OK. And I think in your opening statement
here, you say that the FDA needs to take steps to improve
predictability, consistency and transparency. So the question
is, since you have been there 2 years, I guess rhetorical, why
hasn't all that been done, and maybe more specifically, your
comment that FDA needs to improve management oversight and
standard operating procedures, and I guess the question is,
since you have been there for 2 years have you done that?
Mr. Shuren. So the answer is yes, we have actually already
started to make improvements. When I first came in, there were
a lot of questions from different sides about were the programs
not working well, were we too risk-averse. Others were saying
we are too risk-permissive. And what we said we needed to do is
a thorough assessment of the programs first, understand the
problems, identify the root causes, and then determine the
appropriate solutions. That is what we spent much of 2010
doing. We went around the county to hear from different people,
not just asking people to come to us but our going out to them,
and that is what is contained in our two reports. We put out
the recommendations of what we would do, and we wanted to get
public input first to make sure we were doing what was right
before we proceeded, and in fact, we had heard from industry
and even some in Congress, please don't rush into making
changes, we want to make sure you finish your process first.
So we did that, but we moved quickly so that we could wrap
up and start putting improvements in place, and one of them
already set up is the center science council that I mentioned.
This is a body of our senior managers and experienced
scientists, and to them are brought some of the important
issues to be decided by the center. For example, where in the
past a decision to----
Mr. Stearns. Would it be fair to say what you are talking
about is what you intend to do?
Mr. Shuren. No, no, no. The center science council is
already set up.
Mr. Stearns. OK. Let us say all the things you said are
good things. You heard Dr. Fischell, didn't you, in which he
said the ``FDA's device center over the past few years is the
worst I have experienced in 42 years,'' so then I asked him to
narrow it down, is it 4 years ago, 5 years ago, the last 2
years. He indicated, as you heard, it is really under your
watch. Isn't that what you heard from him?
Mr. Shuren. That is what I heard from him but----
Mr. Stearns. So we both agree, that is what he said. So
under your watch, here is a very competent inventor of the
United States award 200 patents in Europe and the United
States, he said it is the worst experience he has seen in 2
years. Do you agree with him?
Mr. Shuren. No, I don't think we are the worst in terms of
running the center. I do think in terms of performance, we have
seen performance worsen.
Mr. Stearns. So performance has worsened in the last 2
years?
Mr. Shuren. No, it has but it started before then. If I
could show, actually I can show you the data if you would like
to see it. First off, if you would just go to chart number 4.
Mr. Stearns. So he is saying in his opinion, it is worse.
You are saying in a sense that it has been bad but it is not
the worst.
Mr. Shuren. Well, what I----
Mr. Stearns. Would you agree the last 2 years are bad?
Mr. Shuren. What I would like to explain is that
performance has gotten--I think some things are actually now
starting to improve. For example, if you look at the chart
here, this is for 510(k)s. When we have deficient applications
or we have questions, we send out what is called an additional
information letter. If you look at the chart here, the percent
of 510(k)s that we are sending letters out on actually started
to increase in 2002. If you next put up the chart for number
two, you actually see our performance on 510(k)s over time, and
what I want to lay out for you is that there have been issues
here going on many years that have been increasing.
So what you will see on the chart here is our average time
for a decision. The top line is what we call total time. This
is the time it takes FDA and the time it takes industry. The
middle line is FDA's performance. The bottom line is industry
time. What you will see here is that starting in 2005, total
time is going up. In fact, if you overlaid even our first
chart, which you don't have to do, but from 2002 recall those
letters going up. Now watch industry time going up and then
followed after it while our performance started to improve,
total time goes up. If you look at the very end and the numbers
at the end are not done yet, the applications we are looking at
the very end shows 2010.
Mr. Stearns. So in your opinion, things are changing? That
is what you are arguing?
Mr. Shuren. That is what I am trying to say. Things are
starting to change. We have a long way to go.
Mr. Stearns. Long way to go, but you do admit that the last
2 years have been not as, shall we say, competent and----
Mr. Shuren. No, I wouldn't say that. I think for some
indicators in terms of times, those numbers----
Mr. Stearns. Let me get to this quote here. Is FDA
Commissioner Hamburg your boss?
Mr. Shuren. Yes.
Mr. Stearns. You have said that the level of criticism the
device center has received has only compounded the problem. FDA
Commissioner Hamburg, however, acknowledged last week that
``much of the criticism was deserved.'' Has Commissioner
Hamburg expressed this concern to you? Yes or no.
Mr. Shuren. Yes.
Mr. Stearns. If so, when did she give you that criticism to
you?
Mr. Shuren. For over the past year, we have been aware of--
--
Mr. Stearns. So she has criticized for the last year to
you. Is that correct?
Mr. Shuren. What she is conveying is the criticism she has
heard from others and that she and I both agree with, that many
of the concerns raised are accurate.
Mr. Stearns. Did she specifically tell you to do something
about it after she gave this criticism to you?
Mr. Shuren. I started to do something about it from the day
I hit the center. I had heard of these and known about the
problems before I ever took on my job, and one of the very
first things I did when I started was to announce, we need to
look at this. In fact, when I first started the job, I was
acting. I didn't know I would be permanent, and I told the
commissioner, look, if you are going to give me this job, I am
not going to be here and just be a guardian, there are things
we need to do and this is one of the things we need to do, we
need to get to the bottom of what the problems are, and I asked
permission to do that and was told yes, you can proceed----
Mr. Stearns. I think my only concluding comment is that
from our perspective, it looks like you are on the go right now
but you weren't necessarily on the go 2 years ago, and we have
this lag of which Dr. Fischell has talked about and which a lot
of our people in the first panel just complained about, and so
you heard them. So my time is expired.
The gentlelady from Colorado is recognized for 5 minutes.
Ms. DeGette. Dr. Shuren, thank you very much, from my
perspective, for your patience today with the very, very long
day we have had. In my short time, I have a lot of ground to
cover so I want to try to keep this flowing as much as
possible.
It looks to me from the two charts that you put up that the
number of device applications is increasing. Is that correct?
Mr. Shuren. The number of device applications has been
increasing. In fact, since 2004, it has increased through 2010
about 26 percent.
Ms. DeGette. And has the staff in your division of the FDA
increased to keep pace with that?
Mr. Shuren. It hasn't kept pace with the increase in our
workload. If you look from 2007 to 2010, and actually we have a
chart, number six, it will show the increase in workload is
about 27 percent but we have not had the staff increase for
premarket review to handle all that work.
Ms. DeGette. And that is even including the user fees or
the PDUFA fees that are coming up, right?
Mr. Shuren. That is correct.
Ms. DeGette. OK. Now, you said that the 510(k) letters are
going up. Why is that? Is that because of insufficient
applications or the increase in applications, or both?
Mr. Shuren. So we did an analysis of the letters we sent
out in 2010. We looked at about 100 of them and then we looked
at follow-up letters if the manufacturer didn't respond to all
of the deficiencies. The causes for those letters are
multifactorial. In some cases, it is our fault. We found that 8
percent of the time when we sent out letters, we asked for----
Ms. DeGette. I don't mean to stop you, so there are a lot
of reasons why the number of letters are going up?
Mr. Shuren. Sometimes we ask for things we shouldn't. Other
times companies didn't provide information they knew they
should have provided.
Ms. DeGette. OK. Now, you heard me say, and you knew this,
I am the chair of the Diabetes Caucus, and I know that you are
aware of the guidance that the FDA is working on towards
artificial pancreas and also towards these low-glucose
suspending systems that Ms. Sagan was talking about. Are you
familiar with that?
Mr. Shuren. Yes, I am.
Ms. DeGette. Is the agency still on target to have the
guidance on the artificial pancreas approved by December?
Mr. Shuren. Yes.
Ms. DeGette. And can you tell me how the agency is going to
be working with the manufacturers of both the artificial
pancreas and also the pump and glucose monitor combinations on
both of these systems, the artificial pancreas and the low-
glucose suspend systems? How are you going to be working with
manufacturers so we can move these issues along?
Mr. Shuren. So we allow for meetings with the companies
before they are even at a point to actually----
Ms. DeGette. Is that happening?
Mr. Shuren. Yes.
Ms. DeGette. OK.
Mr. Shuren. We do meet with companies, and when we actually
deal with the clinical trial, we have set out for an
interactive review so there is a rapid turnaround. In fact, one
company right now, I just got told by the head of my artificial
pancreas group, he has spoken with the company five times this
week.
Ms. DeGette. OK. Good. So you feel like we are on track
with all of those systems. Because that is important to a lot
of us.
Now, beyond diabetes devices, I want to ask you more
generally, because all of us on this committee on both sides of
the aisle are concerned. You know, you heard the first panel,
we are concerned about all these devices. What other actions is
the FDA taking to improve device review and safety?
Mr. Shuren. So to get the program back on track, we need to
have clearer policies. We need to put clarification of what
companies need to do and our expectations. We need to train our
people and to have training to industry. We need to have the
procedures in place in our center to make sure that the
decisions are made at the right level so that we make the right
call.
Ms. DeGette. And do you think that your staff has
sufficient training or could they need more?
Mr. Shuren. Oh, they do need more.
Ms. DeGette. And is that going to require adequate funding?
Mr. Shuren. We will need to have sufficient funding, not
just to have the training but for the people to take the time
from not doing premarket review so that they can go off and do
the training, and one of the challenges when you have limited
capacity in your staff is that they have to pick and choose
between do I do the training but it is going to take longer on
the premarket review and we would like to have sufficient
number of staff to do the work and ensure people can do the
training and ensure that they can develop the guidance
documents which are so helpful to industry.
Ms. DeGette. Now, you heard Dr. Fischell's idea on the
first panel of just having peer review by people in the field
like putting three people on. What is the FDA's position on
that?
Mr. Shuren. I think the FDA still has responsibility to
review those applications but we need to make far better use of
outside experts, which is why we are setting up four of these
networks of experts so we can go out to people who understand
the new technology, experts in the field, and try to answer
important scientific questions. We will never and can never and
should not expect to have all the expertise in house but we
need to have sufficient expertise in-house so we can reach
outside and have the right kind of conversations to learn from
those outside experts. I am a neurologist. I can talk to
another neurologist. You are not going to send me out to talk
to an orthopedist
Ms. DeGette. OK. Thank you, Doctor.
Mr. Stearns. Dr. Burgess is recognized for 5 minutes.
Mr. Burgess. Submit for the record that no one can talk to
an orthopedist.
Mr. Shuren. My brother is an orthopedist, and I agree with
you.
Mr. Burgess. Dr. Shuren, you have been very good to speak
to me several occasions about some of these problems, and we
have talked about some of the issues regarding the FDA's
regulation, your regulation of laboratory-developed tests. Of
course, we already have the CLIA structure in place that does
that regulation currently. If we are going to talk about
improved safety standards, about thousands of new tests and
many more coming down the pipeline, how do you propose that
FDA, if it going to take on this task and take it away from
CLIA, how do you propose to be able to do that with all the
other stuff that you have got to do?
Mr. Shuren. Well, first off, CLIA doesn't get to the
oversight of the tests, it gets more to the quality of the
laboratory and the ability of a laboratory to perform those
tests, whereas the FDA handles the safety and effectiveness of
the tests. We have been looking at how could we handle that
workload if it were to come in, and that is why any policy we
would put out would be phased in over time to try to address
incoming workload. Secondly, we would be looking at leveraging
our third-party review program we already have to help on
reviewing some of the lower-risk devices, and in addition, we
look at some of the tests to say with experience, maybe we
don't need to look at them premarket, we can down-classify
them, and in fact, just the other week, we down-classified 30
devices that we no longer will be asking for premarket review
on.
Mr. Burgess. I appreciate you being here while we heard the
testimony from all the panelists because I do think it was
important that you hear that. I mean, this is the type of thing
that we hear in our offices or I hear in my office week in and
week out--we have got this thing, we have got this stuff, we
have got this test and it has been in the pipeline for 3 years,
5 years, 17 years and we are no closer today than we were when
we started. So I think it was important that you heard and felt
some of that frustration. And you and I have talked about some
of these things specifically in the past. At some point I would
like to know what we have done at the FDA to improve that
process, but can you give us any idea of the volume of work
that is there bottled up at the FDA right now?
Mr. Shuren. Well----
Mr. Burgess. If you put everybody at every desk and said no
holidays, you don't even get to go home at night until all this
work is finished, would you be able to get that done?
Mr. Shuren. No. Actually----
Mr. Burgess. Since the trial lawyer next to me brought it
up, if this were a plaintiff's firm and this were a product
liability suit or a class action suit, they would have no
trouble sifting through a whole basement full of data,
digitizing it and getting it available to their attorneys in a
relatively short period of time. They would hire enough people
to get that done because it would be important to them, and
what it suggests to me is, this is not important to the FDA.
Mr. Shuren. No, it is important to us, and if I had the
ability to hire more people, I would do so. And we can push our
people, I can chain my people to their desks 24/7, but it is
not like I have one case before me. I have a growing workload
and it doesn't go away.
Mr. Burgess. Now, Mr. Waxman brought up the issue of
funding but it looks like from the information that we have
with the user fee tax that it out there that your funding has
significantly increased over time. So Dr. Sharfstein said he
had plenty of money when I asked him that question a year ago.
Are you telling us differently today?
Mr. Shuren. I think--and I am very happy to go back to the
record. I think what Dr. Sharfstein was saying is that
resources along was not enough to handle it, and I think it was
the context of globalization, but we do need adequate
resources, but let me be clear. Resources are not the only
thing at issue. There are a lot of things at the center that
need to be fixed. We know what the problems are, we know what
to do, and we are on it. We are already making changes. There
are some things we have to work with with industry on. We need
to get the data that they are supposed to send to us, and we
are already in discussions with industry about that. In fact--
--
Mr. Burgess. I am going to have to interrupt you because I
am going to run out of time, but I don't think there is any
question the device times have significantly increased, the
approval times have significantly increased. I am glad to hear
you say it is not just solely due to funding, but we have to
improve.
Now, Michael Mandel was here on our panel earlier. He was
from the Progressive Policy Institute, and he had a story to
tell about this MelaFind, and do you think that the FDA was
impeding the implementation of being able to use this device
that he was describing?
Mr. Shuren. I think in the case, there were issues with the
data that was sent to us. What we are doing now is going
through the data provided, and keep in mind, the manufacturer
then more recently a few months ago changed the indication they
were looking for. We are trying to see, does the data support
what the manufacturer would like to do or something close to
it, and if so, then we would approve that device.
Mr. Burgess. But the fact remains that it has taken so
long, and the rules seem to be changing. Is the FDA causing us
to lose our edge in the development of these new devices?
Mr. Shuren. I think the FDA needs to do a better job to
ensure that we keep our edge as the world's leader in medical
device innovation.
Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
Mr. Stearns. He asked you, do you think we are losing our
edge. Just yes or no.
Mr. Shuren. I don't think we have lost our edge. I think if
there are steps we don't take, we are at risk for losing it in
the future.
Mr. Stearns. Thank you. And the gentleman from California,
Mr. Waxman, is recognized for 5 minutes.
Mr. Waxman. Thank you very much.
Dr. Shuren, I want to ask you about a statement that
Advanced Medical Technology Association, known as AdvaMed, the
medical device industry trade association, issued today. I
would like to ask that this statement be made part of the
hearing record, Mr. Chairman.
AdvaMed is the leading device industry trade group.
According to their Web site, their members produce 90 percent
of the medical devices sold in the United States. Here is what
AdvaMed had to say: ``The medical technology industry has long
recognized that a strong and well-functioning FDA is vital to
maintaining America's preeminence in the medical technology
innovation and we support the current regulatory framework in
the United States.'' Do you have any reaction to this
statement?
Mr. Shuren. I am glad to hear it. Actually, recently I was
in a meeting with senior officials from AdvaMed and they had
said to me that they support the current approval and clearance
standards for the United States.
Mr. Waxman. Well, their press release says that ``we
believe that any steps necessary to address the situation can
be taken without changing the current robust statutory
standards for clearance and approval of medical devices.''
Earlier today, we were hearing from member after member on the
Republican side insisting that the FDA and the regulatory
standards required by the agency for device approval are
destroying innovation and causing device manufacturers to move
overseas. But the leading device manufacturer trade group puts
out a press release that says the best way to maintain
America's preeminence in this area is, and I quote, ``a strong
and well-functioning FDA requiring industry to comply with
robust statutory standards for clearance.'' Now, I assume they
don't want the statutory requirements changed, but when they
talk about a robust FDA, I am sure they are talking about a
well-funded one.
I must take exception to the comment that was made if FDA
really cared, they would hire more people. You are hiring as
many people, I presume, as you can afford. Isn't that correct?
Mr. Shuren. That is correct, and we also suffer from a high
turnover rate, which makes it so much harder to try to keep up
with our losses.
Mr. Waxman. Well, if the Republican budget as proposed
passes, it would provide a 10 percent cut over $200 million in
the FDA budgets. Cut of this magnitude would affect every facet
of FDA operations. You have a tough job to do, balancing the
desire of manufacturers and patients to get quick approval for
devices with your statutory requirements to make sure they are
safe and effective. I think this is shortsighted to make these
kind of budget cuts. Do you differ with me on that?
Mr. Shuren. I am deeply concerned that budget cuts would
cause us to not only lose people but our performance will
worsen, and that will not be in the best interest of industry,
it won't be in the best interest of patients.
Mr. Waxman. Do you have difficulty attracting the best
people?
Mr. Shuren. We do have a challenge attracting the best
people. The circumstances are, it is a high workload for
people. People get burned out. And the pay for our people,
particularly our frontline managers, doesn't compare to what
they get in industry. In fact, in some respects, it is not
necessarily even the same for other parts in the agency and so
we have a very high turnover rate.
Mr. Waxman. So you have a high turnover rate, you have got
a difficult balancing job to do. You recognize other internal
problems that you are trying to deal with in the medical device
area in terms of, I will say it, culture or inability to move
as quickly as we would hope they would, and you are trying to
address those issues?
Mr. Shuren. I am. And in fact, these same problems were
seen in the drug program 10 years ago, same thing in PDUFA
where they had high turnover rate, there were concerns about
slow review times, and the drug program was able to get on top
of it. I think people may have heard Dr. Woodcock the other
week testify, talk about how now they are so much faster than
Europe and there was a health affairs article out about it
recently and what made it, they had to make some internal
changes but ultimately the drug industry got behind the
program. They provided additional funding and that program took
off. In fact, right now the drug program, and I am not saying
it should be the same size but it is three times the size of
the device program. They have five times as many medical
officers. They get 10 times the amount in user fees, and in
fact, 60 percent of their larger program is supporter by user
fees whereas 20 percent of my smaller program is supported by
user fees, and that ultimately made a big difference in being
successful. I hope ultimately our program is much more
successful like the drug program.
Mr. Waxman. Well, we hope so too, and I hope this hearing
will lead to a very constructive approach by a Congress that
has not very well performed so far this year. We have done
practically nothing. We may not even raise the debt ceiling and
allow our economy to go over the cliff, and we are telling you
how to run an agency, but I hope as we do our job and improve
in our job performance that we can help you, not cause more
problems for you.
I see my time is expired and I yield back, Mr. Chairman.
Mr. Stearns. The gentleman's time has expired. The
gentleman from Nebraska is recognized for 5 minutes.
Mr. Terry. Thank you, Dr. Shuren, and I appreciate that you
have outlined some of the areas that you have identified as
needing improvement, so I appreciate that you are willing to do
that. Lisa Jackson is much more fun that you are, frankly, up
here. At least she fights with us instead of coming and
recognizing that there are issues and problems that need
fixing.
Mr. Shuren. I save it for my wife.
Mr. Terry. We share something.
But on the money part, let us start with that, and then I
want to tag along on what Diana was talking about with some of
the artificial pancreas and how we can work through it maybe
even faster, but as I understand from a Congressional Research
Service report, funding from 2008 to 2010 increased 35 percent
for the medical device review process. So it has gone from in
2008 $275 million to $368 million. So I find it hard to really
grasp that the 2-year period that we are talking about, funding
was increased, delays increased, problems occurred and it is
all related to the lack of money. So my question to you is, the
2 years you have served there, there has been an increased of
dollars, you have had a turnover. Is the turnover related to
pay?
Mr. Shuren. Turnover is related to pay and to workload. I
will say in terms of the funding we got--and I haven't seen
that report to look at percentages--but we did get increased
appropriations from Congress. Congress also tells us how that
money should be used, and that money predominantly was directed
towards postmarket safety and globalization, some science. We
really didn't get the big boost for premarket review. We did
get an increase in user fees, which we focused on premarket
review, and if you are talking about the years 2008 to 2010,
the enacted user fees that we can get in 2008 were for my
center, $26.6 million, and they went up to $32.8 million in
2010. So between those two years, I had about an increase in $6
million in user fees, enacted user fees, and those while I have
been on the job, and recall, I came in in late 2009, so I am
dealing with money coming in for 2010, I tried to direct more
money to premarket review. Twenty eleven was a bit of a
challenge because, as you know, I understand the challenges you
all go through.
Mr. Terry. Oh, that is right. We did pass a budget, didn't
we? It is the Senate that hasn't.
Let me get to the low-glucose suspend systems and
artificial pancreas. Do you know how long those have been
before the FDA medical devices for approval?
Mr. Shuren. Well, there is no true artificial pancreas. No
one has developed it. There is nothing commercial. The low-
glucose suspend, the company has come to us, I believe, and
this is my understanding from my staff, but I believe it is
just been in the past year, and we have been working with them
to get up to do the studies they need and ultimately, hopefully
if things turn out right, then approve it and have it on the
market.
Mr. Terry. And the process that has been there for a year,
what information is required at this stage?
Mr. Shuren. So at this stage is to show it is safe and
effective. The device is available in other countries, but from
what we were able to see and particularly in Europe, it wasn't
approved for the low-glucose suspend. It has that as a feature
but it is not in its indications for use, and then we asked,
did you do any of the prospective clinical studies to show that
that feature works, and they hadn't. They didn't need to do
that for Europe, so that is what we are asking for here in the
United States.
Mr. Terry. All right.
Mr. Shuren. And I would like to see such a device out
there, and I will tell you, the head of my artificial pancreas
group, he is a type 1 diabetic. He has said to me, if we have
something out there that worked that was safe and effective, he
would use it.
Mr. Terry. In my last 30 seconds, what do we need to do to
get this done? You have got the JDRF out here, others that are
listening. What is necessary right now?
Mr. Shuren. So right now, we need to get the next guidance
out there. We need to finalize the one we put out on low-
glucose suspend. We need to get the next one out on artificial
pancreas. That will be out on December 1. In the best of all
possible words, I would be able to beef up and have a stronger
staff to focus on this. We deal with so many disease
disciplines that we don't have enough of the people to do all
of that work, and I will tell you in the case of this guidance
that we just put out, I actually pulled endocrinologists from
my other centers and asked them, would you be willing to give
up your time on reviewing drugs and biologics to help us out on
this just so we have the capability to get it done as soon as
possible.
Mr. Terry. My time is up.
Mr. Stearns. The gentleman's time is expired. The gentleman
from Michigan, Mr. Dingell, is recognized for 5 minutes.
Mr. Dingell. Mr. Chairman, I thank you.
Would you please submit us a list of measures you are
taking to improve the consistency of the review process,
please?
Mr. Shuren. Yes.
Mr. Dingell. How many FTEs in your center work on device
review?
Mr. Shuren. The device review process under our user fee
program is 949 FTEs as of 2010.
Mr. Dingell. In your tenure at the center, have you
witnessed a high turnover among the review staff? Yes or no.
Mr. Shuren. Yes.
Mr. Dingell. What is your turnover rate? Would you submit
that for the record, please?
Mr. Shuren. Yes.
Mr. Dingell. Amongst the review staff currently employed by
FDA, what is their average tenure in that position? Please
submit that to the record.
Mr. Shuren. Yes.
Mr. Dingell. Now, as I am sure you are well aware, the
House recently passed H.R. 2112, the fiscal year '12
agriculture appropriations bill, which would cut the FDA budget
by roughly 11 percent, or $285 million. Please submit for the
record what is the result of that on your efforts to improve
the handling of new permits for the devices that we are talking
about. Would you do that, please?
Mr. Shuren. Yes.
Mr. Dingell. Now, if the proposed cuts to the FDA budget
included in H.R. 2112 are enacted, will FDA have to lay off
employees? Yes or no.
Mr. Shuren. Yes, there is a likelihood we may have to lay
off employees.
Mr. Dingell. How many will have to be laid off? Will you
submit that for the record, please?
Mr. Shuren. Yes.
Mr. Dingell. And I want that. I don't want it strained
through OMB. I want that delivered to this committee.
Now, will the proposed cut jeopardize the number of review
staff that FDA is able to employ at the center? Yes or no.
Mr. Shuren. Yes.
Mr. Dingell. By what order of magnitude? Submit that for
the record, please.
Mr. Shuren. Yes.
Mr. Dingell. Will the proposed cut have a detrimental
impact on any efforts to improve reviewer training at the
center?
Mr. Shuren. Yes.
Mr. Dingell. Now, I would note that one of the complaints
that my office consistently receives is that medical device
approval process has a certain inconsistency from reviewers at
the Center for Devices and Radiological Health. Have you taken
steps to improve reviewer training? Yes or no.
Mr. Shuren. Yes.
Mr. Dingell. Would you please define what those are for the
purposes of the record?
Mr. Shuren. Yes.
Mr. Dingell. And would you also submit to us, please, what
steps you are taking to improve the capability of your
reviewers there?
Mr. Shuren. Yes.
Mr. Dingell. Now, there are some areas of improvement in
the current medical device approval process but I would ask my
colleagues here, does anybody remember the Dalkon Shield?
Anybody around here? Well, 3 million American women used that
device. They were assured it was safe in the early 1970s. Yet
the result was widespread cases of pelvic inflammatory disease,
spontaneous abortions, ectopic pregnancies and infertility. I
was here when this committee created a medical device law in
1976 at the urging of my good friend, now deceased, President
Ford, a Republican.
So is there anybody around here that wants to return to
what President Ford called the horse and buggy days of device
regulation? Do you want to do that?
Mr. Shuren. No.
Mr. Dingell. Now, I want to remind everybody here that
first of all, we face huge risks. We talked earlier about
pharmaceuticals that kill people and cause children to be born
with flippers, but I would like to have you tell us what you
have found to be your experience with the money that you have
gotten in terms of having your staff financed in good part by
the funding of your agreements with industry for paying for the
cost of that. Would you submit that for the record, please?
Mr. Shuren. Yes.
Mr. Dingell. And I would ask you to just tell us yes or no,
are you more able to provide the services that you need to do
now that you have that particular program?
Mr. Shuren. Yes.
Mr. Dingell. And of course, that is true in the case of
pharmaceuticals, is it not?
Mr. Shuren. Yes.
Mr. Dingell. Mr. Chairman, I thank you.
Mr. Terry [presiding]. Thank you, Mr. Dingell.
Mr. Bilbray, you are recognized for 5 minutes.
Mr. Bilbray. Doctor, the gentleman from California was
pointing out that, you know, you could have been facing a 10
percent cut in your budget. Are you aware that venture capital
in medical device research is down almost 40 percent? That is
about 30 percent more than the reduction of other venture
capital in high tech.
Mr. Shuren. I don't know the actual figure right now for
investment.
Mr. Bilbray. Would you have any explanation of why those
investors who traditionally went to research in medical devices
would have such a large reduction in proportion to maybe those
who are investing in other high-tech devices that don't relate
to medical?
Mr. Shuren. What I can say in terms of what I have been
told, and told by industry or industry reports, it is
multifactorial. I mean, one is with the global recession,
venture capital investment went down across the board, and the
VCs have become more risk-averse. They are looking for
investing in technologies that are further along in
development. At the same time, there are some things on our
end.
Mr. Bilbray. OK. What----
Mr. Shuren. Insufficient----
Mr. Bilbray. Go ahead.
Mr. Shuren. I was going to say, insufficient predictability
from FDA is something that can also----
Mr. Bilbray. Because that is a huge gap, 30 percent between
venture capital for an iPhone as opposed to venture capital for
a melanoma scanner is a huge gap, and you do say that you think
that the regulatory oversight is one of the major--or a major
problem that we need to address with that discrepancy?
Mr. Shuren. Well, I think having sufficient predictability
is an issue we need to address regardless. I mean, when I
looked at VC investment, and like I said, it was down, some of
the figures from 2010 showed that devices were still the fourth
leading area for investment and had held that way, but I do
understand from the VCs and I do take this seriously that if we
can improve predictability, we can lead to more investment in
device technology.
Mr. Bilbray. OK. Let us talk about a device that was
brought up in the testimony and, you know, there is a lot of
people that don't want their devices or their items brought up
because they are concerned about it affecting their review
process, which I think is a concern in itself, but we are not
here to talk about that. We are talking about something that
was brought up in the first panel, and that is this remote
scanner for melanoma. When we are facing a situation with 3
percent annual increase, annual increase on child melanomas,
8,700 people die a year from this, that we have a device that
may be practical for a general practitioner to use to detect
melanomas that may not be following the regular description,
why was that device basically denied the ability to go through
a review process, a review panel?
Mr. Shuren. The decision the first time around not to have
the device go to the advisory panel was wrong. The staff made
the wrong call. It should have been allowed to go to the
advisory panel. It eventually was. It was supported. It was a
very slim margin. It was 8-7. We went back----
Mr. Bilbray. How much of a delay did that put in?
Mr. Shuren. I don't know.
Mr. Bilbray. Let me just say this. And I don't blame you. I
just blame that--I hope both sides of the aisle understand that
some of us that have worked in government long enough
understand, there is an inherent problem with bureaucracy, and
just accept it. It is just one of those things. There is a
problem with capitalism but there is a problem with government
bureaucracy, and that is, it is too comfortable to say no. It
is too comfortable to show up to the office and go through
basically review stuff, and there is not the push or the
uncomfortable getting something done that you may get at a
different angle, and Doctor, the challenge is, what is the
accountability to the people who said no and how long was this
delay, and I will say this. If you take how many months, and I
will challenge how many months, that this device was slowed
down, how many people died during that period in the United
States from melanoma that could have been avoided possibly if
not just dermatologists but general practitioners had the
ability to detect this down the line, and how do we get the
bureaucracy to understand, this is not about time and it is not
about money, it is about people's lives.
There was a comment made this morning about the delay. Who
was the doctor who was over in the corner, Mr. Chairman?
Fischell. He made the comment that the delay of a few months is
not that big a deal when you consider the life span of a drug
or a device, OK? Would you agree with that statement?
Mr. Shuren. Yes, I do.
Mr. Bilbray. See, my problem is, the people down the aisle
were saying the life span of a device, how about the life span
of a patient, and a couple months, 10 months, 12 months delay,
when you talk about a 12-month delay, how many? Is there 8,700
people that are not going to be detected in this country
because we didn't get a device out to the general practitioners
that might have been able to use it? That is the kind of
concern I would like you to transfer to your rank and file that
every day they say no, every day they say let us study it a
little more, that may be the cause of people dying because
there are two ways of killing somebody in medicine: improper
triage and denying proper triage. And the people that say no
are just as liable, but you don't read about it, and I will
just close with this.
You don't read about those things, you read about the
chairman emeritus talking about a morning sickness medicine in
the 1950s that caused birth defects, and we all talk about
that. We don't talk about in the 1980s when there was a morning
sickness medicine driven off the market and people died because
that was driven off. Nobody hears about those people that died
from not having access to a product. We only hear about those
that die because of inappropriate, and the balance needs to be
there, Dr. Shuren.
Mr. Shuren. And let me say first off from my people, they
will actually get more grief for taking too long, being too
conservative. We are looking at review times, and quite
frankly, if things are moving along quickly, there aren't
issues. When they are moving slowly, that is when management is
coming back and saying we have a problem, and that is when
staff get more grief actually. And in terms----
Mr. Terry. Thank you.
Dr. Green--Dr. Green? I just assumed.
Mr. Green. I am just an old city lawyer.
Mr. Terry. Juris doctorate, the best kind. Right, Mr.
Burgess? The gentleman from Texas, you are recognized for 5
minutes.
Mr. Green. Thank you, Mr. Chairman.
First of all, I want to reiterate and associate myself with
the comments that our ranking member on the studies and how
important the work on the artificial pancreas is, and hopefully
the time frame that I am seeing will be met by December, and
245 Members of Congress actually urged the agency to consider
the draft guidance, so hopefully we will meet those deadlines.
Dr. Shuren, I note that in testimony at other hearings on
the same topic, you stated that delays in the device reviews
and declines in FDA performance are due to poor quality
submissions from the medical device industry. While I agree
with you that not every submission is created equal and there
are certainly some variations in quality, I find it hard to
believe that the dramatic growth we have seen in review times
for both PMA devices and 510(k) devices can be fully explained
by the sudden decline of the quality in submissions. What other
factors explain the dramatic increase in the review times?
Mr. Shuren. So I agree, that is not the explanation,
complete explanation for everything. Some of it is fault on our
end, when we ask for things we shouldn't ask for, and as I
mentioned, that is about 8 percent of those letters we send
out, so about 5 to 6 percent of the 510(k)s we are asking for
things we shouldn't ask for, so we are putting in procedures to
actually make sure that doesn't happen because it should never
happen, but we do have companies who are submitting
applications that are deficient. I am talking about big
concerns where we put out guidance document, it has been out
for years, and says exactly what to do, and the company doesn't
do it and doesn't provide a justification not to do it.
At the same time, we also need to have better clarity on
expectations. I would like to have more guidance out there. We
know when there is guidance, you are more likely to get your
device cleared and cleared quickly, but we need the capability
to do that. I need a core team of writers and I need sufficient
number of experts to do the reviews and do the guidances and
get them out quickly. That can make a big difference.
Mr. Green. And you don't have that ability right now?
Mr. Shuren. We do not have sufficient ability.
Mr. Green. Is it just based on funding? I know others
members have asked questions about that.
Mr. Shuren. It is funding. To the extent we can make our
own systems more efficient, we are doing that. We are doing
what we can with what we have. We can do more if we have more,
and we can do it right.
Mr. Green. What some of us are hearing, particularly
medical device companies are saying there is a lack of
consistency and predictability in the process and sometimes the
rules change in mid-game, and believe me, the FDA would not be
the only federal agency that does that. I can talk about a lot
of agencies. Certainly it is hard to put a quality submission
together, but is that also a problem that sometimes once a
submission is made, like you said, you may be requesting
information that you don't really need or do the rules actually
change once somebody submits?
Mr. Shuren. Sometimes the rules change and it is justified,
there is a new safety concern and we go back to the company and
say we have new information and based upon that we need
additional information, or based on the company's own data, we
have found a problem and we send them back. What we are now
instituting is, when the rules of the road change and they need
to change quickly where we can't take time to get public
comment because of major public health concerns, we are now
going to put out a notice to industry to say things are
changing, here is why and get it out quickly, where before
companies wouldn't find out until they came in the door with
their submission and they wasted their time and effort when
they could have been notified earlier, and we are fixing that.
Mr. Green. I guess just the certainty and consistency, that
is what anybody wants.
I have heard you say previously that the FDA is meeting its
user fee goals for 95 percent of the submissions. When I looked
at the charts from the most recent quarterly update on the
medical device performance goals, there was an awful lot more
goals in the 5 percent that were not being met, and I know that
the 510(k) submissions account for about 95 percent of the
device reviews that FDA does each year but all these red boxes
where the FDA is not meeting its user fee goals are concerning
to me. I also note that goals aren't being made, largely the
PMA goals. In the previous panel, we heard from patients who
could not access these breakthrough technologies and had to
leave the country to get access. What are you doing right now
to rectify that situation and what steps is FDA taking to
ensure that patients have access to this cutting-edge medical
technology?
Mr. Shuren. So in addition to the actions I already
mentioned about making these systems more predictable, more
consistent and more efficient, the other things we are doing
are, we need to adjust clinical trials in the United States. If
we can start clinical trials earlier here, we get the
technology earlier here, companies then keep the technology
with our doctors, so we are going to putting out a policy soon
to actually allow for the first time you give it to a patient,
to let those studies start earlier than we did in the past and
to allow for the manufacturer to make changes, to innovate and
test without necessarily coming back to the FDA. We heard this
is a big deal for the VCs, it is a big deal for the companies.
We will putting out that policy.
The other is being very clear about the factors we take
into account when we make benefit risk determinations. We had
been inconsistent in some cases when we do that. We are for the
very first time going to put out what those factors are. We are
going to get public comment on it, things like taking into
account a patient's tolerance for risk. Serious disease
patients are going to be willing to tolerate more risk. Serious
disease, we may allow for a treatment, particularly if there is
not an alternative out there. That guidance will go out. We
will require that our viewers go through those factors. They
lay out what the answers are and they put in the record. I
consider that so important that actually I chair that working
group personally.
Mr. Green. One quick question. I would like to know, we
have heard a lot of comparisons to the European system and
ours. If there is a device in Europe that has been approved
even with those 74 or whatever they do, can the FDA assess the
success or failure of that device in Europe and do you give any
substance to the quality of any studies that come out of those
that are actually being used in Europe?
Mr. Shuren. So we absolutely will use data from Europe or
from other countries. We do use that data all the time. In some
cases, we have even approved devices that are based
predominantly or, to my understanding, completely on data
outside the United States, but it has to be the data that
actually answers the question, and one of the challenges with
Europe and other countries is, they will let a device on the
market without showing it is effective. So they actually never
generated the data to show it is effective to meet the U.S.
standards, and a lot of those studies are not so robust. In
fact, the British medical journal in a series of investigative
articles, the European Society of Cardiology, a group of
European health technology assessment agencies all came out and
said for high-risk devices, you should be more like the United
States. You should show you are effective. You need to have
more robust clinical studies like the United States. You need
to be transparent like the United States. Tell doctors and
patients the basis of those decisions and put out more guidance
explaining what you need to do. As much as we need to do more
guidance, the EU puts out nothing near what we do to clarify
what kind of studies you have to perform.
Mr. Green. Thank you for your patience.
Mr. Terry. Mr. Scalise, or is it Dr. Scalise?
Mr. Scalise. I am not a----
Mr. Terry. You are recognized for 5 minutes.
Mr. Scalise [continuing]. Juris doctor or a medical doctor.
I just play a Congressman on C-SPAN occasionally here.
I do want to ask a few questions going back to your
testimony, and in a few different sports you talk about the
success of the FDA, and specifically in relation to what is
happening in Europe, and of course, we had a full panel this
morning that was giving I think some very eye-opening, riveting
and not real positive glowing endorsements of FDA's
performance, especially compared to Europe, and you say here
``In terms of time to market, data shows that the United States
is performing as well or better than the European Union,'' and
then you go on to say, ``The EU typically approves higher risk
devices faster than the United States because unlike in the
United States, the EU does not require the manufacturer to
demonstrate that the device actually benefits patients.'' You
had a whole panel of patients sitting here at this table
talking about devices they have access to in Europe that they
would have to go to Europe to get that would actually improve
their lives. Some actually did it. They went to Europe to get
the device. You had Dr. Fischell sitting right there with a
device sitting in front of him that has been waiting on FDA
approval for years that relieves migraine headaches and yet
there is data, there is devices, there is real testing, there
are patients that use it and there are people that are using it
in Europe, and you are implying that Europe has just got some
of Wild West mentality that they are just giving out approval
for things when in fact you have got Americans that right now
have to go to Europe to get the treatment that actually would
and has in some cases improved the lives of those patients. So
how can you make those comments, especially after you sat here
and heard the statements from these patients and the mother of
a patient?
Mr. Shuren. So I can have chart 3, first of all, I
empathize with the patients. I am a physician and a patient
myself. I have loved ones who are patients. I want to get safe
and effective devices but emphasis on safe and effective
devices to patients, patients even like myself.
You asked in terms of the data for performance. This isn't
my study, this is an industry study. They looked at the 510(k)s
without clinical data. That is about 80 percent of the devices
that we review, and the products came on the market first in
the United States as often or more often in the United States
than they did in the EU, and in fact, if you looked at the top
chart, the performance, the likelihood of coming on the U.S.
market first actually has improved more recently in time.
Now, for the smaller group of high-risk devices, they have
come on the market first in other countries for years. We can
do better on that. We can get a lot closer. But we will never
be completely as fast because of that difference in
effectiveness. Does it have ramifications? Yes, because you do
put on the market devices that don't benefit patients, patients
get in some cases when they have alternative that works so they
missed out on good therapy. The health care system paid for
ineffective treatments. And in fact----
Mr. Scalise. I want to go back to something, though,
because again, we had testimony not just from patients but from
doctors who have actually invented devices. I mean, Dr.
Fischell, this is somebody who has been inventing devices for
decades, has been nationally recognized, inventor of the year,
has put out more devices than most doctors in this country, and
he first talked about the change he has seen in the attitude in
the FDA is the last 2 years is the worst he has seen in his 42
years of inventing, and then he further went on to say there is
a different attitude at the FDA than we have ever seen before.
This isn't--you know, you can show metrics all day long but
instead you have patients who are sitting here and you have got
inventors who are sitting here saying the problem they are
seeing in the last 2 years isn't something that they have seen
before at the FDA, and they surely aren't agreeing with your
glowing metrics that you can go find somebody to say how great
you are doing when you have got real inventors, real patients
sitting here saying the job is not getting done. You know, they
will tell you if you want to look at data and compare it to
Europe and say what Europe has or doesn't have. They will say
that firms are willing to submit whatever data you want but
they can't get the certainty in the regulatory process from
your agency. They want to know how to comply. They can't even
get the certainty from you to know how to comply.
And so you can sit here and talk about all the data you are
not getting and all the money you are not getting and all the
turnover you have got. I can tell you, I mean, I have looked at
your budget. Congressional Research Service actually issued a
finding that the medical device review process funding in your
agency has increased 35 percent in the last 2 years. You show
me a family out there as families are cutting back you have got
a 35 percent and you have the nerve to sit here and say you are
not getting enough money and the reason you can't move things
fast enough is because you all have too much turnover. Let me
tell you, I have looked at agencies and especially if you talk
to people in the private sector, they will tell you, if you
have got turnover problems, that is a management problem. You
can't blame that on somebody else. You can't say you are not
getting enough money. You got a 35 percent increase over the
last 2 years, and oh, by the way, during that time, the average
review time increased by 43 percent. So maybe cutting back to
what you were at when you were actually getting some things
done might be the most prudent approach as some of the patients
here said, and so to say that you don't get enough money, you
got a 35 percent increase. The delays are increased. You have
got some management problems I think you have to recognize
before you blame the patients and the inventors who are sitting
here and some have to go to Europe to get the relief that they
have gotten. They actually went to Europe and got the relief
and you still haven't approved the devices here.
So real changes have to occur and you can't just show
metrics that say how great you are doing or say you need more
money. I mean, you know the environment here. We are broke. We
are trying to figure out how to do more with less because we
don't have the money. We can't borrow it from China anymore
and, you know, there has got to be real changes. But you can't
blame other people either.
Mr. Terry. Thank you.
Mr. Scalise. I will yield back the balance of my time,
whatever that balance is, Mr. Chairman.
Mr. Terry. Dr. Christensen, you are recognized for 5
minutes.
Mr. Christensen. Thank you, Mr. Chairman, and Dr. Shuren,
thanks for your patience today.
Let me at least try to help you answer the question about
what is happening with venture capital because the ranking
member earlier reported that Bloomberg News today reported that
in the first quarter of this year, venture capital for medical
device and equipment makers went up 20 percent. That was $841
million in 90 deals, so the first quarter it went up.
But let me try to ask you a question about some other
things that have been discussed today. In this hearing and in
previous hearings before the committee, we have heard from a
variety of industry sources and supporters of weaker or less
rigid regulation about a flawed FDA regulatory process for
medical devices. We have heard a lot about two industry-funded
studies in particular, one by Dr. Josh Makower and one by the
California Healthcare Institute. These studies were critical of
your agency, purporting to show that the FDA process causes
undue delay in approvals. We asked leading medical experts to
provide us with their views on the methodology of these
studies, and we asked FDA to provide the views of the agency.
So Dr. Shuren, first, can you tell us about the FDA's views on
the findings of the Makower and the California Healthcare
Institute studies?
Mr. Shuren. So we did have concerns about the methodologies
that were used. For example, in the Makower study, he sent out
a survey to 1,000 companies, not to the full industry. Of that,
he got 204 who responded, and then on particular questions
trying to compare the United States to the EU, at most, the
number of people who could actually had a device in both might
have been 60 to 80. So very underreporting, and in those cases,
we know the people who are most dissatisfied, that is who
reports. Most of these companies did not have much experience
with the FDA. Only 55 percent brought a 510(k) through the
process, only 32 percent a PMA.
Much of the methodology to compare time frames was apples
to oranges. They didn't look at the same point in time between
the EU and the United States. They compared a first
communication with the United States which could occur before
you even do a clinical study where in the EU your first
communication may be before you actually submit the
application. And therefore I could reduce those times
dramatically if I didn't meet with companies and just say give
me the submission and our times would dramatically improve. In
fact, the best way to compare is, if we had the data from the
EU and comparable times for reviews, and in fact it doesn't
exist because the EU doesn't keep it and doesn't report it.
Mr. Christensen. Thanks. Well, your views are really
similar to the views of the outside experts that are described
in the supplemental memo that was shared today. These experts
also identified a variety of problems. One reviewer concluded
that there so many flaws in the design and execution that the
author's conclusions are rendered essentially meaningless.
Another reviewer concluded that the CHI study reflects little
or no understanding of the complexity of medical devices. All
reviewers indicated that these studies would not stand up to
basic scientific peer review.
So Dr. Shuren, would you agree that these industry studies
are so flawed that they should not be used as the basis to
justify a radical change to the FDA device safety standards?
Mr. Shuren. I would not be using them in terms of the
actual numbers and data behind them, and that is why we tried
to actually go and pull what the real numbers look like. On the
flip side, in some of the studies that have come out, they
raised what concerns are and some of the problems that are
raised like high turnover rate, insufficient guidance, those
are issues that we agree need to be addressed. That is why we
are taking the steps that we are taking, but we shouldn't base
decisions based on flawed data. That doesn't serve anyone well.
Mr. Christensen. I agree.
Mr. Chairman, we have important decisions to make on this
committee as we work towards reauthorizing the Medical Device
User Fee Act, and we can't really afford to base these
decisions on fatally flawed and biased studies.
Mr. Shuren. If I may just say quickly, by the way, that
chart is from one of the flawed studies, and I put it up
because, you know, if you put it out there, it is out there. It
is not my data, that even industry in their own study reported
what comparisons between the United States and the EU, so just
that is on the record.
Mr. Christensen. I am just curious. I understand that
Europe might be forming some kind of unified committee to more
standardize their review of their medical devices and probably
medication. Do you know anything about that and how close they
are, and might that not make a difference in how FDA might
accept some of the data?
Mr. Shuren. Ultimately, I don't know what the EU will
decide. We should find out in 2012. But they have been going
through a whole process to review their own system because of
complaints that were about it, about not uniform, inconsistent,
not providing adequate patient protections. In fact, the
clinical director for the UK counterpart to my agency just last
year said I am appalled at how many devices are brought to
market with a lack of appropriate clinical data. The fact that
much more clinical data and evaluation is needed and the
notified bodies, there are over 70 private companies, do not
know how to adequately assess or challenge clinical data or
tell those companies relying on equivalents that they actually
need to do a clinical investigation. These are commercial
organizations, many of whom are reluctant to challenge because
they fear losing their clients and for their survival, and
these are one of the things leading to that review in the EU
and maybe potentially changes over there, and that is the call
you heard from the European Society of Cardiology and the
British medical journal to actually in some respects make some
things more like the United States.
Mr. Christensen. Thank you. Thank you, Mr. Chairman.
Mr. Stearns. The gentleman from Virginia, Mr. Griffith, is
recognized for 5 minutes.
Mr. Griffith. Thank you, Mr. Chairman.
I was pleased to hear you talk about tolerance for risk,
and if you have a high-risk patient, they are more willing to
take--you know, the patient who has got a serious illness
willing to take some risk. I am wondering if the reverse is
true in relationship to the treatment, and it sounds like it
isn't, because I heard you talk about the European and some of
the doctors said on a high-risk device they wish it was more
like the American systems. But I am thinking about low-risk
devices. I am thinking about Ms. Sagan's testimony when I say
this, because, you know, as long as there is a caveat or a
statement that says, you know, this hasn't been through 50
years of marketing or testing on humans, her daughter would be
in a much better shape to have something that would shut off
the insulin pump and the daughter would know and her mom would
know that, you know, even if it doesn't work, it is better than
what they have got right now. Even if it doesn't work 100
percent, it is better than what they have right now.
Every human being is different, and I would point that out
to you because we had testimony from the other lady that she
had the migraine fix for her 5 years ago, if I remember
correctly--I may be off on the number of years--but years ago
because she was part of a trial, and for 9 months she had a
normal life, and it sounds like in listening to that testimony
this morning that that was a fairly low-risk medical device
that could have been brought to bear, and everything isn't
going to work for everybody, and having a huge study that says
it is effective for 99 percent of the population isn't always
going to be the way to go.
I did a little data research, you know, on accidents in
ambulances, and I am not going to ambush you with it but I will
just tell you about it. Because if you take the theory that I
was hearing this morning that we have a certain number of
deaths, we had 300 deaths in an 11-year period in automobile
accidents while people were in ambulances. We had 24 deaths in
a single year with med-evac. Well, if you took that and applied
it to what the FDA has been doing from what I heard in
testimony today, that means you wouldn't allow the med-evacs or
the ambulances to be out there because notwithstanding the fact
that it might help thousands of people, some people died. And I
understand that you have to be careful but you have to take
that into account. And so I would have to say to you that you
might want to look at a risk-versus-benefit analysis and if the
risk is low and the benefit might be great, get that thing out
there quicker because, you know, we heard testimony from people
who are suffering who could really use some help, and I
understand, if you are putting something inside somebody's body
that is going to be there for hopefully 20 years, that is a
different situation. I understand what the Europeans are saying
about high-risk devices. But we were hearing testimony this
morning about devices that sounded like to me--now, I am a
lawyer, not a doctor, and maybe I wrong, but it sure didn't
sound like they were high-risk devices to me, that it seemed
more high risk not to have, for Ms. Sagan's daughter not to
have something that at least--you know, even if it worked most
of the time would shut that insulin off. That doesn't mean she
still wouldn't have risk because she is diabetic but it would
seem to me that that would be the better course, and I don't
know how you fix that, and if you need us to help, come see me,
I will do what I can.
That being said, I would also say in regard to venture
capital that Chris Coburn, the head of the Cleveland Clinic
Innovation, stated last week raising capital is harder, given
the current economy and health care reform creates a lot of
unknowns. Raising capital is harder. Health care reform creates
a lot of unknowns in the current timeline. You add in
regulatory delays and all of a sudden the arithmetic of
developing products domestically starts to break down. So it is
not just folks coming in here with some kind of a political
agenda, this was just a talk that he was giving somewhere, and
I am just wondering if you would submit them later because my
time is almost up what steps you might be taking on all of
these things that I have mentioned.
And then also I would say apparently at a recent hearing of
the Committee on Oversight and Government Reform, you mentioned
that sometimes reviewers ask for data that might not be
necessary, and I am wondering what you are doing about that
because the industry indicates that is a relatively recent
phenomenon. We heard testimony this morning that one of the
parts on the migraine invention that Dr. Fischell was talking
about, he said he had a plastic valve he showed us, and he said
this is already used in all kinds of different devices but now
I have to show them it works again, even though it has already
been approved in other devices, just that valve, and I am just
wondering what steps you are taking to correct that. Where
would people have gotten the idea that asking questions like
that is acceptable, and do you have a process in your industry
if you have different teams looking at different things to say
well, wait a minute, team A already approved this valve and it
looks like it is pretty good.
So I would ask you to submit those to us for the record and
so that I can review those as well, and I know I fired a lot at
you and I only have 19 seconds for you to respond, but anything
you want, you can say.
Mr. Shuren. Well, I will give you an example of some of the
things we are doing to ensure we make the right decision and
consistent. So if you are going to the review team says we want
to ask for a new kind of study for a type of device, that is
being brought to this new center science council so rather than
a decision made low down in the organization, it is coming up
to the senior managers and experienced scientists and medical
officers to review to make a call as to whether or not that is
right. That allows for looking over the program for
consistency, to make sure that decision is well informed
because we may turn around and say we disagree. Those are the
kinds of changes we are putting in place that if you are going
to make a change, it has to be made at the right level in the
organization. I still want to give my reviewers flexibility,
but when big decisions are being made, I need the right people
to be involved in making that call.
Mr. Griffith. Thank you, Mr. Chairman.
Mr. Stearns. All right. The gentleman's time is expired. I
think we are going to do a second round and then you are free
to go, so we appreciate your waiting here.
Just to be clear, you are citing what appears to us as a
flawed study in your testimony, what you said in your opinion
in your testimony and on the report here. Is that right? Does
that make sense to you?
Mr. Shuren. Oh, yes, for the California Healthcare
Institute?
Mr. Stearns. Right.
Mr. Shuren. Yes, I do think there are parts in terms of
some of the data they provided that I would disagree with and
how it is presented.
Mr. Stearns. OK. I just wanted to put that on the record.
The gentleman from Texas, Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Shuren, thank you for staying with us so long. Part of
the review of the 510(k) process, the FDA allocated $1.3
million to the Institute of Medicine to convene a committee to
evaluate the 510(k) effect on patient safety and innovation.
The IOM committee will have a very influential role including
reviewing seven of the FDA's most controversial
recommendations. Now, in February of this year at a Health
Subcommittee hearing, you seemed to have some concern that the
IOM committee itself would lack the patient advocates,
innovators and inventors who are familiar with the 510(k)
system. Critical omissions raise questions as to credibility of
the IOM recommendations and why the FDA would pay $1.3 million
in taxpayer money for such recommendations. Is that a fair
observation?
Mr. Shuren. I don't think I had raised concerns about it. I
think some of the members were raising concerns in terms of the
panel makeup. And what I did try to put out at the time is----
Mr. Burgess. Are not our concerns your concerns?
Mr. Shuren. Concerns by the members, some of the members
who are on the committee.
Mr. Burgess. They should be your concerns. If they are our
concerns----
Mr. Shuren. Well, I understand, and what I tried to say too
is, we contract with the IOM. We don't make a decision in terms
of who are on the panels or what they look at. I will tell you,
though, that, what comes back from them are recommendations.
They are not making a decision; they are recommendations. And
if they make a recommendation, if we are thinking of adopting
it and it would have an impact, a big impact on industry or
others, we will go out and seek public comment first. If it is
a recommendation that pertains to legislation, that is not our
call.
Mr. Burgess. Have they made recommendations to the FDA?
Mr. Shuren. No, I have not seen anything from the IOM yet.
Mr. Burgess. Now, there is a lawyer from the University of
Minnesota named Ralph Hall who has concerns that the IOM
committee violates the Federal Advisory Committee Act. Are you
aware of that opinion from Dr. Hall?
Mr. Shuren. Yes.
Mr. Burgess. And if that is the case, it would be illegal
for you to implement the recommendations of the IOM committee
that violated the Federal Advisory Committee Act, correct?
Mr. Shuren. I think he raised the concern of, is the
committee fairly balanced, and there are people on that
committee who have experienced developing 510(k)s to come to
the agency, there are people with experience dealing with
510(k)s within the agency.
Mr. Burgess. Did the IOM committee certify that it had
complied with section 15 of the Federal Advisory Committee Act?
Mr. Shuren. I don't know if they certified.
Mr. Burgess. Well, but you are telling us today that you
will not institute any of the IOM committee recommendations
until some of these questions are resolved?
Mr. Shuren. I will not implement any of the recommendations
if we wanted to adopt, there would be recommendations we may
decide we are not going to adopt. But if there are
recommendations that would have a big impact on industry or
others, we would seek public comment before we would proceed.
Mr. Burgess. But why spend $1.3 million to a committee that
doesn't have patients and doesn't have anyone with any medical
device-related experience, especially innovators?
Mr. Shuren. The Institute of Medicine is a well-respected,
well-regarded organization that government has turned to,
Congress has turned to many times for outside----
Mr. Burgess. But shouldn't they have at least one patient
representative on those committees?
Mr. Shuren. I would direct to the Institute of Medicine in
terms of the decisions made.
Mr. Burgess. And again, I would direct your attention to
the overall legality of whether or not they complied with
section 15 of the Federal Advisory Committee Act.
Let me ask you this. There are complaints that the FDA has
not communicated with companies what is needed in the
submissions. The FDA is not telling companies in advance, and
what will happen is, 50 to 75 days later after the submission
you all will come back with what was needed in the submission,
so obviously that upsets and frustrates the companies because
of the added time, and I think we heard Mr. Bilbray comment on
that fact. What are you doing to ensure that companies are
notified in advance about what is needed and then thereby
included in the submitted applications?
Mr. Shuren. First, I would say there are other occasions
where companies know what to do, we have told them what to do,
and they don't do it, and I appreciate the fact of hearing that
companies will provide us what we need to receive, and I have
heard that before, but we have companies that actually don't do
that. They don't give us, even in spite of laying out what they
need to do. I will give you a very quick example, something
called the pulse oximeter that actually----
Mr. Burgess. I know what it is.
Mr. Shuren. And you know what it is, just for the other
members. It is a sensor you can put on your finger and it will
tell you how much oxygen is in the blood. We have had guidance
since, I believe, 1992. We updated it in 2007. It said you need
to do a very simple clinical study. It is sort of you use this
and you measure from the blood and see if it is accurate. We
recently had a company come in, didn't send us any clinical
data, and we go back to them, why not, and we ask again, where
is the clinical data, we have laid this out for years. We do
deal with those circumstances, so it goes back and forth.
For the cases where we can provide more clarity, I would
like to be able to put out more guidance for industry and to
update our guidances more quickly. I would like to have the
capacity to go ahead and do that.
Mr. Burgess. And I think we would like for you to do that.
I would like the assurance that a company comes to you with a
novel device and says what are we going to need to do to comply
with your guidelines to get the submission completed in a
timely fashion. I would like to be certain that they are
getting that information upfront the first time and it doesn't
change throughout the submission of that application.
Mr. Shuren. Well, one of the things we are doing are what
we call pre-submission meetings if you come in, let us say,
before you are going to do a clinical trial or before you
submit your application. We are going to be putting out
guidance probably by November that now for the first time it
lays out here are the expectations for company, what they have
to give to us, here are the expectations of what you can expect
to see from the agency, and that includes our putting down what
is our advice, and then standing behind it, assuming that
device doesn't change in an important--you change what the use
is for, you change the technological characteristics that may
have been. But if not, then we should be standing behind it and
that is going to be put out in our guidance later this year.
Mr. Burgess. And on your Web site?
Mr. Shuren. The guidance will be on our Web site. In fact,
it will be out for public comment before we finalize it. All
the things I am talking about from guidance, all go for public
comment. In fact, some of the things we don't normally put out
for public comment we are doing like that notice to industry
letters, which is an internal action, we put out standard
operating procedures of what we would do and when, we asked for
public comment on it. It is out right now for folks to weigh
in.
Mr. Stearns. The gentleman's time is expired.
The gentlelady from Colorado is recognized for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
I just want to ask you a couple of follow-up questions, Dr.
Shuren. The first one is, the question about the funding levels
because the chairman had said in April 2010 there was a CRS
report that said the medical device review process funding
increased from $275 million in fiscal year 2008 to $368 million
in fiscal year 2010, but that funding as I understand it
includes user fees. Is that correct?
Mr. Shuren. Yes, and I believe that is more than for my
center because my numbers for my center are a little bit lower.
Ms. DeGette. What are your numbers?
Mr. Shuren. What I have from my enacted and my total budget
for 2008 is $225 million, and this is what I am given from my
budget people, and from 2010, it is $272.7 million, and that is
comprised of appropriations and user fees.
Ms. DeGette. How much of that is user fees? Do you know?
Mr. Shuren. So in 2008, the enacted amount is $26.6
million, and the amount in 2010 is $32.8 million. And I say
enacted because under the law, if we collect more than we are
supposed to in the first 4 years, we have to give it back by
lowering our fees in 2012, and in fact we are going to be doing
that. Fees will go down in 2012.
Ms. DeGette. Now, when we enacted the user fees in the
MDUFA legislation in 2002, that allowed the funding to increase
in better proportion to the costs of the agency. Is that right?
Mr. Shuren. That is correct. There was an adjustment factor
after our workload went up we could increase accordingly. That
was taken out in I think 2005, 2006. It remains in for the drug
program. They can adjust accordingly.
Ms. DeGette. Would that be something that would be worth
having the larger committee look at when we go towards the
reauthorization next year?
Mr. Shuren. We should look at how to account for increasing
workload. I would like to provide user fees predictability for
industry. I know that is important. But we also need to make
sure that if our workload goes up, we get the sufficient
resources to meet the workload. Otherwise we are not going to
be able to meet our timeframes.
Ms. DeGette. So a lot of the device companies have
expressed to me concern that if the user fees are too high and
if we--and this is same thing actually the drug people say is--
if they are too high, that that freezes out a lot of innovation
and a lot of the kinds of creative devices that we might really
want to see. What is your reaction to that?
Mr. Shuren. Well, you have the ability to actually adjust
the fees accordingly, dependent upon even for the type of
company. I will tell for a 510(k), full fee right now is about
$4,300. For a small business, and a small business is $100
million or less in annual sales receipts, it is about $2,100
for a 510(k).
Ms. DeGette. So that is not really an onerous fee.
Mr. Shuren. PMA is higher. It is about $236,000 for full.
For a small company, it is $59,000. A lot of the PMAs tend to
come from the bigger companies. More of the 510(k)s come from
the smaller companies.
Ms. DeGette. OK.
Mr. Shuren. Which is why we developed the fees as we did.
That is what we worked out with industry to spread that cost.
Ms. DeGette. Now, in the budget that some of my colleagues
were talking about that was approved by the House and not the
Senate earlier this year, the overall FDA was cut by about 10
percent under H.R. 1. Were you given any indication if that
budget went through how much of those cuts would go to your
agency?
Mr. Shuren. For my center, my understanding is that if you
take how much would be cut plus not getting the increases for a
fixed cost like my rent goes up every year that I have to pay
but it is out of my control, it is about 12-1/2 percent.
Ms. DeGette. You would be cut by 12-1/2 percent. Do you
think this would have an effect even with some of these user
fees on your ability to expedite some of these applications?
Mr. Shuren. Yes, it would have an impact on our ability to
do reviews. I mean, we can cut the funding. We cannot increase
user fees but then people have to manage their expectations as
to what kind of device program they are going to get. The drug
industry said you know what, it is worth it to us. A robust FDA
gets us better performance and we can see that today.
Ms. DeGette. And that was proven to be correct, right?
Mr. Shuren. That was proven to be correct, and I understand
the unique circumstances of the device industry. I honestly do.
But then we have to figure out some way to have the right
program, and if it is not there, then people need to
understand, you know, what you get in return.
We need to do a better job at the FDA. We know that. We are
doing it. That is what I am talking about today. There are some
things we need industry to work on and then we need adequate
resources to do it right. That is good for companies. It is
ultimately good for patients, and that is what this is all
about.
Ms. DeGette. I think that is kind of a good place to end
it, Mr. Chairman.
Dr. Shuren, I appreciate your candor with this committee
and your ability and willingness to discuss the deficiencies at
the agency, and I think all of us really need to sit down with
you as we move towards the reauthorization next year of the
user fees to talk about what we really need to do to make it
work because there are a lot of devices out there that can save
lives and we want to make sure that they are reviewed quickly,
that they are reviewed thoroughly, that they are safe and they
are approved. So thank you very much.
Mr. Shuren. I appreciate that, and I would like to have the
ability to work with you all, and I also hope that if the
things we are talking about are right, to also have your
support as we move forward.
Mr. Stearns. Dr. Shuren, I would expect, you know, maybe we
will have another hearing sometime in the future just to follow
up with all these things you are saying. You know, obviously
you mentioned all these things you are doing, and I think the
turnover rate is something you have to figure out too because I
think lots of times organizations where you work, turnover rate
is low even though they are not paid a lot of money because of
esprit de corps, because of the mission and the patriotism and
whatever else, leadership is involved, so----
Mr. Shuren. Well, we actually did an assessment in my
center. The esprit de corps is actually off the charts compared
to the rest of my government. My people are very committed.
Mr. Stearns. I don't know if that is good or bad.
Mr. Shuren. It is good in the right way. I will say, we
have the same problem in the drug program. They had a high
turnover rate. They were able to cut it and they have been able
to maintain it low, and they did it with targeted retention
allowances, by having enough staff to do the work, get away
from a sweatshop mentality and have enough managers and project
managers to run that program.
Mr. Stearns. Are all the guidances on FDA's Web site the
current state of the thinking at FDA staff? If we go to that
site, will we find the latest and the greatest state of
thinking?
Mr. Shuren. I would not be surprised if we have guidances
that are probably not fully up to date.
Mr. Stearns. So your Web site is not up to date?
Mr. Shuren. No, the Web site is up to date as to the
current guidance. I will say that we do run into cases where
our thinking for that kind of device may chance and the
guidance hasn't gotten updated in time.
Mr. Stearns. All right.
Ms. DeGette. Mr. Chairman, just before we adjourn, some
housekeeping. You had asked unanimous consent to put this
Medtronic case into the record. Mr. Waxman had asked UC for
this AdvaMed press release, and then we had asked UC for Dr.
Shuren's slides. Are those all agreed to?
Mr. Stearns. By unanimous consent, so ordered.
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Ms. DeGette. Thank you.
Mr. Shuren. May I just clarify one thing?
Mr. Stearns. Yes.
Mr. Shuren. But if the thinking has changed with the
guidance, what we are trying to do is update the guidance first
so people know but if not and we need to make a quick change
because there is new information, there really is a risk you
have to deal with, then we are going to these notice to
industry letters, so that----
Mr. Stearns. You have heard a lot of our panel today. I
would think they would help you, and you are going to go to
private industry first too. You are going to go there too,
right?
Mr. Shuren. For feedback on the process?
Mr. Stearns. Yes.
Mr. Shuren. We have already--it is out for anybody to
comment on.
Mr. Griffith. Mr. Chairman?
Mr. Stearns. Congressman Griffith.
Mr. Griffith. I was wondering if I could have just a minute
to ask a question.
Mr. Stearns. Sure, sure.
Mr. Burgess. But before you do, because I have got--I just
wanted to ask unanimous consent to put these two letters from
Senator Kerry and the Massachusetts delegation into the record
on the IOM study of the 510(k) process.
Mr. Stearns. While you are looking from that, the gentleman
from Virginia for 1 minute.
Mr. Griffith. I heard you talk about your lease, so I am
switching gears on you into something I am a little more
comfortable with than medical devices, and I guess my question
is, you said your rent goes up every year. I was wondering how
long your lease was for and when was the last time you went and
renegotiated with your landlord. Because I think it is
something the federal government doesn't do. I am not picking
on you all. I don't have any idea.
But a lot of times they just got locked into a lease and
circumstances in the economy have changed, and when I took
office I was able to cut the lease cost of actually more square
footage, not as pretty but more square footage for about half
the cost, and I am just wondering as your costs are going up,
you might want to take a look at your lease and see if you
can't renegotiate. Even if you are locked into a multi-year
lease, you might be able to renegotiate.
Mr. Stearns. That is good. That is experience talking.
We will put this in by unanimous consent.
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Mr. Stearns. Thank you very much for your patience. The
subcommittee is adjourned.
[Whereupon, at 6:08 p.m., the subcommittee was adjourned.]
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